SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01200797
First received: September 10, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This phase II trial is studying how well SJG-126 works in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: SJG-136
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    The exact 95% confidence interval of the response rate will be reported.

  • Nature and degree of toxicity, graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: The time from start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days ] [ Designated as safety issue: No ]
    The possible risk factors will be compared for survival with Kaplan-Meier estimates and log-rank tests. The proportional hazard model will be used for adjusted tests of significance and estimates of odds ratios.

  • Overall survival [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    The possible risk factors will be compared for survival with Kaplan-Meier estimates and log-rank tests. The proportional hazard model will be used for adjusted tests of significance and estimates of odds ratios.

  • Time to progression [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2010
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (SJG-136)
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: SJG-136
Given IV
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the overall response rate to SJG-136 in patients with persistent or recurrent platinum-refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

II. To assess the nature and degree of toxicity of this regimen in these patients.

III. To determine other parameters of response, including progression-free survival, overall survival, and time to progression in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. To correlate response rates with the degree of DNA adduct formation in peripheral blood mononuclear cells (PBMCs) and tumor cells as measured by the single-cell gel electrophoresis (Comet) assay and γ-H2AX assay.

II. To assess whether the rate of DNA adduct formation in PBMCs correlates with the rate of DNA adduct formation in tumor cells.

III. To evaluate BRCA1 protein expression in archival tissue specimens from the patient's primary tumor reductive surgery.

IV. To determine the ability of BRCA1 protein in repairing/removing DNA-adducts in PBMCs and tumor tissue.

VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to SJG-136.

OUTLINE: This is a multicenter study.

Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected.

After completion of study therapy, patients are followed up for 30 days and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma

    • Persistent or recurrent disease
    • No borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord stromal tumors, or other non-epithelial ovarian tumors
  • Must have had >= 1 prior platinum-based (cisplatin or carboplatin) chemotherapy regimen for the management of primary disease

    • Intraperitoneal chemotherapy allowed
  • Platinum-refractory or -resistant meeting 1 of the following criteria:

    • Progression of disease during platinum-based chemotherapy
    • Persistent disease at the completion of platinum-based chemotherapy
    • Less than 6 months of disease-free interval after completion of platinum-based therapy
  • Measurable disease
  • Archived tissue available from the original tumor debulking surgery for assessment of BRCA1 protein expression
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • WBC >= 3,000/mm^3
  • ANC >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal
  • Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for >= 3 months after completion of study therapy
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with the study requirements
  • No prior malignancy except cervical carcinoma in situ, ductal carcinoma in situ of the breast, nonmelanoma skin cancer, or curatively treated malignancy without evidence of disease within the past 3 years
  • No baseline organ dysfunction or symptoms that qualify as >= grade 2 by CTEP CTCAE v 4.0

    • Alopecia or other situations in which the organ dysfunction or symptoms are considered clinically insignificant or irrelevant to the study allowed
  • No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or surgery for cancer (including resection of metastases)
  • No more than 3 prior treatment regimens for epithelial ovarian, primary peritoneal, or fallopian tube carcinoma

    • Consolidation or maintenance therapy initiated within 6 weeks after the completion of primary therapy will not be counted as an additional regimen
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgery and recovered
  • No prior radiotherapy to > 25% of the bone marrow
  • No prior SJG-136 or related compounds
  • No other concurrent investigational agents
  • No concurrent palliative radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200797

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Oncology Associates PC
Hartford, Connecticut, United States, 06106
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
Principal Investigator: Marta Crispens H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01200797     History of Changes
Obsolete Identifiers: NCT01199796
Other Study ID Numbers: NCI-2011-02519, VICC GYN 1003, MCC-VICC-GYN-1003, CDR0000682791, N01CM00100
Study First Received: September 10, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014