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Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cisplatin
paclitaxel
topotecan hydrochloride
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein Clinical Cancer Center
  • New York Hospital Medical Center of Queens
  • Saint Vincent Catholic Medical Center of New York
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center, NY
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • New York Medical College
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
November 8, 2012
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005051
Brief Title
Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard S. Hochster, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York Hospital Medical Center of Queens
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Saint Vincent Catholic Medical Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3236
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

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