Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovary Cancer |
Drug: Topotecan Drug: Paclitaxel Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Overall response rate
- Overall toxicity
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2002 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193297 History of Changes |
| Other Study ID Numbers: | SCRI GYN 08, 104864-644 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Ovary Cancer |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carboplatin Paclitaxel Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013