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
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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 |
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | January 2100 (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 |
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| United States, Connecticut | |
| Oncology Associates PC | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Robert D. Siegel 860-545-3034 rsiegel@harthosp.org | |
| Sub-Investigator: Robert D. Siegel | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Marta A. Crispens 615-322-2114 marta.crispens@vanderbilt.edu | |
| Principal Investigator: Marta A. Crispens | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | Active, not recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Marta A. Crispens 615-322-2114 marta.crispens@vanderbilt.edu | |
| Principal Investigator: Marta A. Crispens | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Cecelia H. Boardman 804-828-9080 chboardm@vcu.edu | |
| Sub-Investigator: Cecelia H. Boardman | |
| 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 |
| Other Study ID Numbers: | NCI-2011-02519, VICC GYN 1003, N01CM00100 |
| Study First Received: | September 10, 2010 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Ovarian Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Genital Neoplasms, Female Urogenital Neoplasms Fallopian Tube Diseases |
Adnexal Diseases Genital Diseases, Female Neoplasms by Histologic Type Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013