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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Ovary Cancer

Treatments

Drug: Carboplatin

Drug: Topotecan

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193297

SCRI GYN 08

104864-644

Details and patient eligibility

About

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.

Full 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

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.