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| Sponsor: | Rigshospitalet, Denmark |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003732 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: paclitaxel Drug: topotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Denmark | |
| Rigshospitalet - Copenhagen University Hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Svend Aage Engelholm, MD 45-3545-4088 saengel@rh.dk | |
| Study Chair: | Svend Aage Engelholm, MD | Rigshospitalet, Denmark |
More Information
| Study ID Numbers: | CDR0000066847, DAN-104864/373, DAN-104864-A/373, EU-98052, SB-104864-A/373, SB-104864/373 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003732 History of Changes |
| Health Authority: | Unspecified |
|
stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
|
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Carboplatin |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Topotecan Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |