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

NCT ID: NCT00193297

Last Updated: 2011-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2006-06-30

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

Conditions

Ovary Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topotecan

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

SCRI

Principal Investigators

Anthony Greco, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

104864-644

Identifier Type: -

Identifier Source: secondary_id

SCRI GYN 08

Identifier Type: -

Identifier Source: org_study_id