Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
This study has been completed.
Sponsor:
New York University School of Medicine
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005051
First received: April 6, 2000
Last updated: November 8, 2012
Last verified: December 2003
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC) |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
| Study Start Date: | August 1999 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxicity and tolerance of sequential therapy with prolonged
- Determine the response rate and time to progression in this patient
- Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.
OUTLINE:
- Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
- Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
- Stage IC, II, III, or IV
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT no greater than 3 times upper limit of normal
- Bilirubin no greater than 2.0 mg/dL
- No clinically significant hepatic disorder
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No clinically significant renal disorder
Cardiovascular:
- No clinically significant cardiovascular condition
Other:
- Normal GI function allowing reliable administration of oral medication
- No active infection requiring systemic medical therapy within past week
- No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No dementia or altered mental status that would preclude consent
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for ovarian epithelial carcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for ovarian epithelial carcinoma
Surgery:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005051
Locations
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| New York Hospital Medical Center of Queens | |
| Fresh Meadows, New York, United States, 11365 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Saint Vincent Catholic Medical Center of New York | |
| New York, New York, United States, 10011 | |
| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
| New York, New York, United States, 10019 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-3236 | |
Sponsors and Collaborators
New York University School of Medicine
Investigators
| Study Chair: | Howard S. Hochster, MD | New York University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00005051 History of Changes |
| Other Study ID Numbers: | CDR0000067644, NYU-9913, NCI-G00-1720 |
| Study First Received: | April 6, 2000 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Cisplatin Carboplatin |
Paclitaxel Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs 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