Status:
COMPLETED
Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ovary Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ova...
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00193297
Start Date
February 1 2002
End Date
June 1 2006
Last Update
May 3 2011
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