Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer

Phase 2

Terminated

• Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

• Registration Number: NCT00003880
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells.

PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.

Detailed Description

OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups: Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6 weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-08
• Study Completion: 2001-08
• Study First Submitted QC: 2004-04-22
• Study First Posted: 2004-04-23
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified