Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005051
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride Phase 2

Detailed Description:


  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : August 1999
Primary Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery

    • Stage IC, II, III, or IV



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • SGOT no greater than 3 times upper limit of normal
  • Bilirubin no greater than 2.0 mg/dL
  • No clinically significant hepatic disorder


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min
  • No clinically significant renal disorder


  • No clinically significant cardiovascular condition


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for ovarian epithelial carcinoma

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for ovarian epithelial carcinoma


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005051

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
Saint Vincent Catholic Medical Center of New York
New York, New York, United States, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, United States, 10019
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
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
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT00005051     History of Changes
Other Study ID Numbers: CDR0000067644
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: December 2003

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
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors