AZD2171 in Treating Patients With Progressive Locally Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying AZD2171 to see how well it works in treating patients with progressive locally recurrent or metastatic kidney cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: cediranib maleate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma |
- Objective response rate and rate of stable disease ≥ 4 months [ Designated as safety issue: No ]
- Duration of response or stable disease [ Designated as safety issue: No ]
- Progression-free, median, and overall survival [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Correlation of levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome [ Designated as safety issue: No ]
- Correlation of changes in blood flow and vessel permeability with clinical outcome [ Designated as safety issue: No ]
| Estimated Enrollment: | 37 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the clinical benefit rate (objective response rate and rate of stable disease for ≥ 4 months) in patients with progressive unresectable, locally recurrent or metastatic renal cell carcinoma treated with AZD2171.
- Determine the duration of response or stable disease in patients treated with this drug.
- Determine progression-free, median, and overall survival of patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
- Correlate levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome in patients treated with this drug.
- Correlate changes in blood flow and vessel permeability with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell cancer
- Locally recurrent or metastatic disease
- Progressive unresectable disease
- Not considered curable by standard therapy
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Bone lesions are not considered measurable disease
- Sole site of measurable disease may lie within a previously irradiated field provided there has been subsequent documented disease progression
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 60 mL/min
- No proteinuria > +1 on 2 consecutive dipstick tests taken ≥ 1 week apart
Cardiovascular
- QTc ≤ 470 msec (with Bazett's correction) by ECG
- No history of familial long QT syndrome
- No hypertension
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
No New York Heart Association class III or IV disease
- Class II disease with increased monitoring is allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy or gene therapy
- No drugs or biologics with proarrythmic potential
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy, except low-dose, non-myelosuppressive radiotherapy, and recovered
- No concurrent radiotherapy to the sole site of measurable disease
Surgery
- At least 4 weeks since prior major surgery and recovered
Other
- No prior investigational therapy
- No prior participation in another investigational study
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
Contacts and Locations| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Srikala Sridhar, MD, FRCPC, MSC | Princess Margaret Hospital, Canada |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00227760 History of Changes |
| Other Study ID Numbers: | CDR0000446080, PMH-PHL-039, NCI-7128 |
| Study First Received: | September 26, 2005 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent renal cell cancer stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms |
Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Maleic acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013