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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovary Cancer

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Principal Investigator

Anthony Greco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GYN 08

NCT ID:

NCT00193297

Start Date:

February 2002

Completion Date:

June 2006

Related Keywords:

  • Ovary Cancer
  • Ovary Cancer
  • Carcinoma
  • Ovarian Neoplasms

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