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Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer - Article


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Oxaliplatin Injection

Eloxatin



Clinical Trial: Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Kaplan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Condition Treatment or Intervention Phase
recurrent ovarian epithelial cancer
Fallopian Tube Cancer
peritoneal cavity cancer
 Drug: oxaliplatin
 Drug: topotecan
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Ovarian Cancer;   Reproductive Health

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Oxaliplatin and Topotecan in Patients With Previously Treated Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed through day 30.

PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 4 months

Hematopoietic:

  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No uncontrolled symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia

Other:

  • No other active cancer
  • No prior allergy to platinum compounds
  • No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study
  • No other uncontrolled concurrent illness (e.g., infection)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • See Chemotherapy
  • No concurrent colony stimulating factors during topotecan administration

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • No unresolved sequelae resulting from prior surgery

Other:


Location Information


New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Howard S. Hochster, MD,  Study Chair,  Kaplan Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068275; NYU-0016; NCI-690
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006391
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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