Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Phase 2

Completed

• Conditions: Ovary Cancer

• Registration Number: NCT00193297
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.

Detailed Description

Upon determination of eligibility, all patients will be receive:

Paclitaxel + Carboplatin + Topotecan

a maximum of six courses of chemotherapy will be given at 21 day intervals

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Epithelial ovarian carcinoma or primary peritoneal carcinoma
• Willing to consider second-look surgery to evaluate response if necessary
• No previous treatment with chemotherapy or radiation therapy
• Ability to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney function
• Written informed consent

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Age < 18 years
• Brain metastases
• Recent history of significant heart disease within 6 months
• Other significant medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Overall toxicity