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.
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. Correlative Endpoints: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Given IV
Correlative studies
Hartford Hospital
Hartford, Connecticut, United States
Oncology Associates PC
Hartford, Connecticut, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Overall Response (OR)
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD. Confirmation of CR or PR is required to deem either one the best overall response.
Time frame: On-treatment date to date of disease progression (assessed up to 12 months)
Number of Patients With Each Worst-grade Toxicity
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death.
Time frame: On-study date to 30 days following final dose of study
Progression-free Survival (PFS)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Time frame: On-study date to lesser of date of progression or date of (assessed up to 12 months)
Overall Survival (OS)
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details).
Time frame: On-study date to date of death from any cause (assessed up to 12 months)
Time to Progression (TTP)
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Time frame: On-study date to date of progression (assessed up to 12 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.