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

Ovary Cancer Clinical Trial

Official title:

A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193297
• Other study ID #: SCRI GYN 08
• Secondary ID: 104864-644
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: February 2002
• Est. completion date: June 2006

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovary Cancer

Intervention

Drug:
• Topotecan

• Paclitaxel

• Carboplatin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Overall toxicity

External Links

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