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Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005051
First received: April 6, 2000
Last updated: November 8, 2012
Last verified: December 2003

April 6, 2000
November 8, 2012
August 1999
March 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005051 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: paclitaxel
  • Drug: topotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2003   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005051
CDR0000067644, NYU-9913, NCI-G00-1720
Not Provided
New York University School of Medicine
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine
New York University School of Medicine
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP