Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: topotecan hydrochloride

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein Clinical Cancer Center
    • Fresh Meadows, New York, United States, 11365
      • New York Hospital Medical Center of Queens
    • New York, New York, United States, 10016
      • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center, NY
    • New York, New York, United States, 10021
      • New York Weill Cornell Cancer Center at Cornell University
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center at Columbia University
    • New York, New York, United States, 10011
      • Saint Vincent Catholic Medical Center of New York
    • New York, New York, United States, 10019
      • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-3236
      • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: April 6, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 8, 2012
• Last Verified: December 1, 2003

More Information

Terms related to this study

• Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Paclitaxel; Topotecan
• Other Study ID Numbers: CDR0000067644; NYU-9913; NCI-G00-1720