NCT01200797

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

A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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. 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.

Conditions

• Recurrent Fallopian Tube Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	SJG-136	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-10-01
• Completion: 2013-02-01
• First posted: 2010-09-14
• Last updated: 2015-05-25
• Results posted: 2015-05-25

Locations

6 sites across 1 country: United States