Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Ovarian Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005051
• Other study ID #: CDR0000067644
• Secondary ID: NYU-9913NCI-G00-
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: November 8, 2012
• Start date: August 1999

Study information

• Verified date: December 2003
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• paclitaxel

• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	New York Hospital Medical Center of Queens	Fresh Meadows	New York
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Saint Vincent Catholic Medical Center of New York	New York	New York
United States	St. Luke's-Roosevelt Hospital Center - Roosevelt Division	New York	New York
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,