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Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer - Article


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Oxaliplatin Injection

Eloxatin



Clinical Trial: Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

This study is no longer recruiting patients.

Sponsored by: University Hospitals of Leicester
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 II trial to study the effectiveness of combining oxaliplatin and fluorouracil in treating patients who have recurrent ovarian cancer.

Condition Treatment or Intervention Phase
recurrent ovarian epithelial cancer
 Procedure: chemotherapy
 Drug: fluorouracil
 Drug: leucovorin calcium
 Drug: oxaliplatin
Phase II

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Oxaliplatin and Fluorouracil in Patients With Recurrent Ovarian Cancer

Further Study Details: 

Study start: September 1999

OBJECTIVES: I. Determine the efficacy of oxaliplatin in combination with fluorouracil in terms of response rate, time to tumor progression, and overall survival in patients with recurrent ovarian cancer. II. Evaluate the safety profile of this combination regimen in this patient population.

PROTOCOL OUTLINE: This is an open label study. Patients receive oxaliplatin IV over 2 hours once every 2 weeks and fluorouracil IV and leucovorin calcium IV once weekly. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease are followed at 1 month and at 3 months, then every 3 months for disease relapse and survival.

PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: No concurrent immunotherapy
  • Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: At least 3 weeks since prior radiotherapy and recovered
  • Surgery: Not specified
  • Other: At least 30 days since prior investigational agents

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-2
  • Life expectancy: At least 12 weeks
  • Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL
  • Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) (unless documented Gilbert's syndrome); AST/ALT less than 3 times ULN (less than 5 times ULN if liver metastases present)
  • Renal: Creatinine normal
  • Cardiovascular: No unstable cardiovascular disease
  • Other: No active, uncontrolled infection; No other significant medical disorder or condition that would preclude study; No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Location Information


United Kingdom, England
      University Hospitals of Leicester, Leicester,  England,  LE1 5WW,  United Kingdom

Study chairs or principal investigators

Kenneth O'Byrne,  Study Chair,  University Hospitals of Leicester   

More Information

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

Study ID Numbers:  CDR0000067452; LRI-IND.02-V3; EU-99036
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  January 21, 2000
ClinicalTrials.gov Identifier:  NCT00004206
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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