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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193297

Enrollment

Registered

2005-09-19

Start date

2002-02-28

Completion date

2006-06-30

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovary Cancer

Keywords

Ovary Cancer

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

Interventions

DRUGTopotecan

DRUGPaclitaxel

DRUGCarboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Overall toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026