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Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
This study has been completed.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005051
  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 II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cisplatin Paclitaxel Carboplatin Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: 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)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1999
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
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
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 Hospital Medical Center of Queens
Fresh Meadows, New York, United States, 11365
New York Medical College
Valhalla, New York, United States, 10595
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
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

Study ID Numbers: CDR0000067644, NYU-9913, NCI-G00-1720
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005051     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin
Ovarian Epithelial Cancer
Genital Diseases, Female
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Topotecan
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Endocrine Gland Neoplasms
Ovarian Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Topotecan
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009