Oxaliplatin Injection |
Eloxatin |
Clinical Trial: Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer
This study is no longer recruiting patients.
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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
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--
- Histologically confirmed ovarian cancer
- Must have received at least one prior platinum based chemotherapy regimen and have relapsed within 2 years of last chemotherapy regimen
- Evaluable disease; Radiology confirmation AND/OR Elevated CA 125 (at least 60 IU/L)
--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
Kenneth O'Byrne, Study Chair, University Hospitals of Leicester
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Eloxatin (Drug Digest)
- Oxaliplatin Injection (Drug Digest)

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