Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

This study has been completed.
Sponsor:
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
  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)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
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:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Cisplatin
Paclitaxel
Topotecan
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014