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CompletedNCT00005051Updated Nov 9, 2012

Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

A Phase 2 interventional study of carboplatin and cisplatin in Ovarian Cancer, sponsored by NYU Langone Health. Completed at 10 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.

Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
06

Study locations

10 sites
  • New York Hospital Medical Center of Queens
    Fresh Meadows, New York 11365, United States
  • Saint Vincent Catholic Medical Center of New York
    New York, New York 10011, United States
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    New York, New York 10016, United States
  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
    New York, New York 10019, United States
  • New York Weill Cornell Cancer Center at Cornell University
    New York, New York 10021, United States
  • Mount Sinai Medical Center, NY
    New York, New York 10029, United States
  • Herbert Irving Comprehensive Cancer Center at Columbia University
    New York, New York 10032, United States
  • Albert Einstein Clinical Cancer Center
    The Bronx, New York 10461, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-3236, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005051
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Aug 1999
Primary completion
Mar 2003
Last update
Nov 9, 2012

Study contacts

Howard S. Hochster, MD
study chair · NYU Langone Health
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Carboplatin · Cisplatin · Paclitaxel · Topotecan

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