A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
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.
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
VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The exact 95% confidence interval of the response rate will be reported.
Up to 30 days
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Virginia Commonwealth University||Richmond, Virginia|
|Oncology Associates PC||Hartford, Connecticut 06106|