Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

This study has been completed.

Sponsor:

Collaborators:

National Cancer Institute (NCI)

Eli Lilly and Company

Kanisa Pharmaceuticals

Information provided by:

Eastern Cooperative Oncology Group

ClinicalTrials.gov Identifier:

NCT00046930

First received: October 3, 2002

Last updated: June 21, 2011

Last verified: December 2010

History of Changes

Results First Received: August 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Leukemia Myelodysplastic Syndromes
Interventions:	Biological: filgrastim Biological: sargramostim Drug: cytarabine Drug: daunorubicin hydrochloride Drug: zosuquidar trihydrochloride Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Zosuquidar	Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo	Induction treatment with daunorubicin, cytarabine and placebo

Participant Flow: Overall Study

	Zosuquidar	Placebo
STARTED	224	225
COMPLETED	212	221
NOT COMPLETED	12	4
Ineligible	12	4

Baseline Characteristics

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Reporting Groups

	Description
Zosuquidar	Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo	Induction treatment with daunorubicin, cytarabine and placebo
Total	Total of all reporting groups

Baseline Measures

	Zosuquidar	Placebo	Total
Number of Participants [units: participants]	212	221	433
Age [units: years] Mean ± Standard Deviation	69.4 ± 5.5	69.2 ± 5.3	69.3 ± 5.4
Gender [units: participants]
Female	103	85	188
Male	109	136	245

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]

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2. Secondary:

Progression-free Survival (PFS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]

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3. Secondary:

Response [ Time Frame: Assessed at the end of induction ]

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Serious Adverse Events

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Time Frame	Assessed every day until discharged from hospital, then twice weekly until ANC and platelets returned to normal levels. Complete blood counts were obtained monthly for 12 months, then every other month for 12 months.
Additional Description	In addition to lab assessed as above, clinical events were reported via case report forms at the end of Induction, Consolidation I, and Consolidation II. After the end of treatment, forms were collected every 3 months for 2 years, then every 6 months for 3 years. CTCv2 reports were electronically mapped to CTCAE3.

Reporting Groups

	Description
Zosuquidar Induction	Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo Induction	Induction treatment with daunorubicin, cytarabine and placebo
Consolidation I	Cytarabine 1500 mg/m2 days 1-6
Zosuquidar Consolidation II	Consolidation with Daunorubicin, Cytarabine and Zosuquidar
Placebo Consolidation II	Consolidation with Daunorubicin, Cytarabine and Placebo

Serious Adverse Events

	Zosuquidar Induction	Placebo Induction	Consolidation I	Zosuquidar Consolidation II	Placebo Consolidation II
Total, serious adverse events
# participants affected / at risk	216/219 (98.63%)	218/222 (98.20%)	173/180 (96.11%)	59/59 (100.00%)	69/70 (98.57%)
Blood and lymphatic system disorders
Bone Marrow Hypocellularity ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Anemia ^{† 1}
# participants affected / at risk	160/219 (73.06%)	152/222 (68.47%)	94/180 (52.22%)	32/59 (54.24%)	37/70 (52.86%)
Hemolysis ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Leukopenia ^{† 1}
# participants affected / at risk	205/219 (93.61%)	211/222 (95.05%)	167/180 (92.78%)	58/59 (98.31%)	66/70 (94.29%)
Lymphopenia ^{† 1}
# participants affected / at risk	3/219 (1.37%)	5/222 (2.25%)	3/180 (1.67%)	1/59 (1.69%)	2/70 (2.86%)
Neutropenia ^{† 1}
# participants affected / at risk	200/219 (91.32%)	202/222 (90.99%)	153/180 (85.00%)	48/59 (81.36%)	61/70 (87.14%)
Thrombocytopenia ^{† 1}
# participants affected / at risk	210/219 (95.89%)	214/222 (96.40%)	169/180 (93.89%)	48/59 (81.36%)	61/70 (87.14%)
Transfusion: Platelets ^{† 1}
# participants affected / at risk	20/219 (9.13%)	23/222 (10.36%)	20/180 (11.11%)	5/59 (8.47%)	10/70 (14.29%)
Transfusion: Peripheral Red Blood Cells ^{† 1}
# participants affected / at risk	18/219 (8.22%)	18/222 (8.11%)	15/180 (8.33%)	4/59 (6.78%)	8/70 (11.43%)
Hematologic - Other ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Disseminated Intravascular Coagulation ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Thrombotic Microangiopathy ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Hemorrhage, GI, Hematemesis ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	1/70 (1.43%)
Hemorrhage, GU, Hematuria ^{† 1}
# participants affected / at risk	3/219 (1.37%)	3/222 (1.35%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Hemorrhage, Upper Respiratory, Hemoptysis ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hemorrhage Associated with Surgery ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hemorrhage, GI, Melena ^{† 1}
# participants affected / at risk	5/219 (2.28%)	4/222 (1.80%)	0/180 (0.00%)	0/59 (0.00%)	3/70 (4.29%)
Petechiae ^{† 1}
# participants affected / at risk	7/219 (3.20%)	13/222 (5.86%)	8/180 (4.44%)	0/59 (0.00%)	4/70 (5.71%)
Hemorrhage, GI, Rectum ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hemorrhage, GU, Vagina ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Lymphatics, Other ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Cardiac disorders
Conduction Abnormality ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Dysrhythmia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Sinus Bradycardia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Sinus Tachycardia ^{† 1}
# participants affected / at risk	4/219 (1.83%)	5/222 (2.25%)	2/180 (1.11%)	0/59 (0.00%)	0/70 (0.00%)
Supraventricular Arrhythmia ^{† 1}
# participants affected / at risk	16/219 (7.31%)	8/222 (3.60%)	4/180 (2.22%)	0/59 (0.00%)	0/70 (0.00%)
Ventricular Arrhythmia ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Arrhythmia - Other ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Cardiac Ischemia ^{† 1}
# participants affected / at risk	4/219 (1.83%)	2/222 (0.90%)	1/180 (0.56%)	1/59 (1.69%)	0/70 (0.00%)
Cardiac - Left Ventricular Dysfunction ^{† 1}
# participants affected / at risk	6/219 (2.74%)	8/222 (3.60%)	3/180 (1.67%)	2/59 (3.39%)	1/70 (1.43%)
Cardiac Troponin I Increased ^{† 1}
# participants affected / at risk	2/219 (0.91%)	2/222 (0.90%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Cardiac Troponin T Increased ^{† 1}
# participants affected / at risk	2/219 (0.91%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Acute Vascular Leak Syndrome ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypertension ^{† 1}
# participants affected / at risk	3/219 (1.37%)	7/222 (3.15%)	0/180 (0.00%)	1/59 (1.69%)	0/70 (0.00%)
Edema ^{† 1}
# participants affected / at risk	6/219 (2.74%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypotension ^{† 1}
# participants affected / at risk	16/219 (7.31%)	9/222 (4.05%)	2/180 (1.11%)	1/59 (1.69%)	1/70 (1.43%)
Cardiac, Other ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Endocrine disorders
Neuroendocrine: ADH Secretion Abnormality ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Eye disorders
Conjunctivitis ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Vision - Blurred ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Nystagmus ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Keratitis ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Gastrointestinal disorders
Anorexia ^{† 1}
# participants affected / at risk	29/219 (13.24%)	20/222 (9.01%)	5/180 (2.78%)	3/59 (5.08%)	4/70 (5.71%)
Ascites ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Colitis ^{† 1}
# participants affected / at risk	5/219 (2.28%)	3/222 (1.35%)	3/180 (1.67%)	1/59 (1.69%)	2/70 (2.86%)
Constipation ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Dehydration ^{† 1}
# participants affected / at risk	4/219 (1.83%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	1/70 (1.43%)
Heartburn/Dyspepsia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Dysphagia ^{† 1}
# participants affected / at risk	10/219 (4.57%)	2/222 (0.90%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Ulcer, Gastric ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Nausea ^{† 1}
# participants affected / at risk	18/219 (8.22%)	12/222 (5.41%)	3/180 (1.67%)	1/59 (1.69%)	1/70 (1.43%)
Pancreatitis ^{† 1}
# participants affected / at risk	2/219 (0.91%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Stomatitis ^{† 1}
# participants affected / at risk	19/219 (8.68%)	11/222 (4.95%)	3/180 (1.67%)	3/59 (5.08%)	2/70 (2.86%)
Typhlitis ^{† 1}
# participants affected / at risk	3/219 (1.37%)	2/222 (0.90%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	6/219 (2.74%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Diarrhea w/o Prior Colostomy ^{† 1}
# participants affected / at risk	16/219 (7.31%)	13/222 (5.86%)	5/180 (2.78%)	4/59 (6.78%)	4/70 (5.71%)
Diarrhea w/Colostomy ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
GI, Other ^{† 1}
# participants affected / at risk	4/219 (1.83%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Pain, Abdomen ^{† 1}
# participants affected / at risk	8/219 (3.65%)	5/222 (2.25%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Pain, Rectum ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	38/219 (17.35%)	22/222 (9.91%)	8/180 (4.44%)	4/59 (6.78%)	2/70 (2.86%)
Fever w/o neutropenia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Rigors/Chills ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Constitutional, Other ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Pain, Other ^{† 1}
# participants affected / at risk	3/219 (1.37%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hepatobiliary disorders
Liver Dysfunction/Failure ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hepatic, Other ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	1/70 (1.43%)
Infections and infestations
Infection, Catheter Related ^{† 1}
# participants affected / at risk	5/219 (2.28%)	8/222 (3.60%)	2/180 (1.11%)	2/59 (3.39%)	3/70 (4.29%)
Febrile Neutropenia ^{† 1}
# participants affected / at risk	93/219 (42.47%)	82/222 (36.94%)	42/180 (23.33%)	12/59 (20.34%)	15/70 (21.43%)
Infection w/ Grade 3 or 4 Neutropenia ^{† 1}
# participants affected / at risk	119/219 (54.34%)	121/222 (54.50%)	57/180 (31.67%)	29/59 (49.15%)	26/70 (37.14%)
Infection w/ Unknown ANC ^{† 1}
# participants affected / at risk	1/219 (0.46%)	3/222 (1.35%)	2/180 (1.11%)	0/59 (0.00%)	0/70 (0.00%)
Infection without Neutropenia ^{† 1}
# participants affected / at risk	8/219 (3.65%)	7/222 (3.15%)	17/180 (9.44%)	3/59 (5.08%)	4/70 (5.71%)
Infection, Other ^{† 1}
# participants affected / at risk	2/219 (0.91%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Injury, poisoning and procedural complications
Hemorrhage, Other ^{† 1}
# participants affected / at risk	12/219 (5.48%)	3/222 (1.35%)	4/180 (2.22%)	0/59 (0.00%)	3/70 (4.29%)
Investigations
Fibrinogen Decreased ^{† 1}
# participants affected / at risk	0/219 (0.00%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Prolonged Partial Thromboplastin Time ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
PT (INR) Increased ^{† 1}
# participants affected / at risk	1/219 (0.46%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Alkaline Phosphatase Increased ^{† 1}
# participants affected / at risk	2/219 (0.91%)	4/222 (1.80%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Bilirubin Increased ^{† 1}
# participants affected / at risk	36/219 (16.44%)	31/222 (13.96%)	2/180 (1.11%)	4/59 (6.78%)	1/70 (1.43%)
Gamma-glutamyl Transpeptidase (GGT) Increased ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypoalbuminemia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
ALT, SGPT Increased ^{† 1}
# participants affected / at risk	5/219 (2.28%)	8/222 (3.60%)	2/180 (1.11%)	0/59 (0.00%)	1/70 (1.43%)
AST, SGOT Increased ^{† 1}
# participants affected / at risk	8/219 (3.65%)	11/222 (4.95%)	2/180 (1.11%)	0/59 (0.00%)	2/70 (2.86%)
Acidosis ^{† 1}
# participants affected / at risk	1/219 (0.46%)	3/222 (1.35%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Alkalosis ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Amylase Increased ^{† 1}
# participants affected / at risk	2/219 (0.91%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Bicarbonate, Serum Decreased ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hyperglycemia ^{† 1}
# participants affected / at risk	7/219 (3.20%)	3/222 (1.35%)	2/180 (1.11%)	0/59 (0.00%)	0/70 (0.00%)
Hyperkalemia ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypermagnesemia ^{† 1}
# participants affected / at risk	3/219 (1.37%)	2/222 (0.90%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Hypernatremia ^{† 1}
# participants affected / at risk	2/219 (0.91%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hyperuricemia ^{† 1}
# participants affected / at risk	4/219 (1.83%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypocalcemia ^{† 1}
# participants affected / at risk	17/219 (7.76%)	7/222 (3.15%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypoglycemia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hypokalemia ^{† 1}
# participants affected / at risk	16/219 (7.31%)	12/222 (5.41%)	3/180 (1.67%)	6/59 (10.17%)	1/70 (1.43%)
Hypomagnesemia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Hyponatremia ^{† 1}
# participants affected / at risk	11/219 (5.02%)	3/222 (1.35%)	3/180 (1.67%)	2/59 (3.39%)	1/70 (1.43%)
Hypophosphatemia ^{† 1}
# participants affected / at risk	13/219 (5.94%)	4/222 (1.80%)	3/180 (1.67%)	2/59 (3.39%)	1/70 (1.43%)
Lipase Increased ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Ataxia ^{† 1}
# participants affected / at risk	17/219 (7.76%)	2/222 (0.90%)	5/180 (2.78%)	2/59 (3.39%)	0/70 (0.00%)
Proteinuria ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Metabolism and nutrition disorders
Tumor Lysis Syndrome ^{† 1}
# participants affected / at risk	6/219 (2.74%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Musculoskeletal and connective tissue disorders
Pain, Joint (Arthralgia) ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	1/70 (1.43%)
Pain, Bone ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	1/70 (1.43%)
Pain, Muscle (Myalgia) ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	1/180 (0.56%)	0/59 (0.00%)	1/70 (1.43%)
Nervous system disorders
Muscle Weakness ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	1/59 (1.69%)	0/70 (0.00%)
Cerebrovascular Ischemia ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Confusion ^{† 1}
# participants affected / at risk	18/219 (8.22%)	3/222 (1.35%)	1/180 (0.56%)	3/59 (5.08%)	0/70 (0.00%)
Psychosis (Hallucinations/Delusions) ^{† 1}
# participants affected / at risk	24/219 (10.96%)	10/222 (4.50%)	2/180 (1.11%)	0/59 (0.00%)	0/70 (0.00%)
Somnolence/Depressed Level of Consciousness ^{† 1}
# participants affected / at risk	8/219 (3.65%)	4/222 (1.80%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Dizziness/Lightheadedness ^{† 1}
# participants affected / at risk	3/219 (1.37%)	0/222 (0.00%)	2/180 (1.11%)	0/59 (0.00%)	1/70 (1.43%)
Insomnia ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Memory Impairment ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Mood Alteration: Anxiety/Agitation ^{† 1}
# participants affected / at risk	3/219 (1.37%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Mood Alteration: Depression ^{† 1}
# participants affected / at risk	1/219 (0.46%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Neuropathy, Motor ^{† 1}
# participants affected / at risk	4/219 (1.83%)	2/222 (0.90%)	1/180 (0.56%)	1/59 (1.69%)	1/70 (1.43%)
Neuropathy, Sensory ^{† 1}
# participants affected / at risk	1/219 (0.46%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Seizure ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Speech Impairment ^{† 1}
# participants affected / at risk	4/219 (1.83%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Pyramidal Tract Dysfunction ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	0/180 (0.00%)	1/59 (1.69%)	0/70 (0.00%)
Syncope ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	2/180 (1.11%)	1/59 (1.69%)	0/70 (0.00%)
Tremor ^{† 1}
# participants affected / at risk	5/219 (2.28%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Neurologic - Other ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Pain, Headache ^{† 1}
# participants affected / at risk	1/219 (0.46%)	2/222 (0.90%)	2/180 (1.11%)	0/59 (0.00%)	0/70 (0.00%)
Renal and urinary disorders
Renal, Other - Dysuria ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Incontinence, Urinary ^{† 1}
# participants affected / at risk	2/219 (0.91%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Renal Failure ^{† 1}
# participants affected / at risk	4/219 (1.83%)	4/222 (1.80%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Urinary Frequency/Urgency ^{† 1}
# participants affected / at risk	0/219 (0.00%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Urinary Retention ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Renal, Other ^{† 1}
# participants affected / at risk	2/219 (0.91%)	1/222 (0.45%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Upper Respiratory, Nose ^{† 1}
# participants affected / at risk	12/219 (5.48%)	13/222 (5.86%)	2/180 (1.11%)	2/59 (3.39%)	4/70 (5.71%)
Pain, Pleura ^{† 1}
# participants affected / at risk	0/219 (0.00%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Adult Respiratory Distress Syndrome (ARDS) ^{† 1}
# participants affected / at risk	4/219 (1.83%)	0/222 (0.00%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Dyspnea ^{† 1}
# participants affected / at risk	22/219 (10.05%)	21/222 (9.46%)	3/180 (1.67%)	1/59 (1.69%)	1/70 (1.43%)
Hypoxia ^{† 1}
# participants affected / at risk	16/219 (7.31%)	12/222 (5.41%)	2/180 (1.11%)	1/59 (1.69%)	0/70 (0.00%)
Pneumonitis/Pulmonary Infiltrates ^{† 1}
# participants affected / at risk	13/219 (5.94%)	11/222 (4.95%)	2/180 (1.11%)	0/59 (0.00%)	2/70 (2.86%)
Voice changes/Dysarthria ^{† 1}
# participants affected / at risk	2/219 (0.91%)	2/222 (0.90%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Pulmonary, Other ^{† 1}
# participants affected / at risk	4/219 (1.83%)	4/222 (1.80%)	0/180 (0.00%)	0/59 (0.00%)	0/70 (0.00%)
Skin and subcutaneous tissue disorders
Pruritis/itching ^{† 1}
# participants affected / at risk	0/219 (0.00%)	0/222 (0.00%)	1/180 (0.56%)	0/59 (0.00%)	0/70 (0.00%)
Rash/Desquamation ^{† 1}
# participants affected / at risk	10/219 (4.57%)	4/222 (1.80%)	2/180 (1.11%)	0/59 (0.00%)	1/70 (1.43%)
Wound, Infectious ^{† 1}
# participants affected / at risk	1/219 (0.46%)	2/222 (0.90%)	2/180 (1.11%)	1/59 (1.69%)	0/70 (0.00%)
Vascular disorders
Thrombosis/Embolism ^{† 1}
# participants affected / at risk	1/219 (0.46%)	2/222 (0.90%)	0/180 (0.00%)	1/59 (1.69%)	1/70 (1.43%)

†	Events were collected by systematic assessment
1	Term from vocabulary, CTCAE (3.0)

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

Publications of Results:

Cripe LD, Li X, Litzow M, et al.: A randomized, placebo-controlled, double blind trial of the MDR modulator, zosuquidar, during conventional induction and post-remission therapy for Pts > 60 years of age with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): ECOG 3999. [Abstract] Blood 108 (11): A-423, 2006.

Publications automatically indexed to this study:

Cripe LD, Uno H, Paietta EM, Litzow MR, Ketterling RP, Bennett JM, Rowe JM, Lazarus HM, Luger S, Tallman MS. Zosuquidar, a novel modulator of P-glycoprotein, does not improve the outcome of older patients with newly diagnosed acute myeloid leukemia: a randomized, placebo-controlled trial of the Eastern Cooperative Oncology Group 3999. Blood. 2010 Nov 18;116(20):4077-85. Epub 2010 Aug 17.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00046930 History of Changes
Obsolete Identifiers:	NCT00046046
Other Study ID Numbers:	CDR0000257122, E3999, U10CA021115
Study First Received:	October 3, 2002
Results First Received:	August 17, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration

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