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Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Leicester Royal Infirmary
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004206
  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 Intervention Phase
Ovarian Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Oxaliplatin    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 1999

Detailed Description:

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.

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 older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004206

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

Sponsors and Collaborators
Leicester Royal Infirmary

Investigators
Study Chair:     Kenneth O'Byrne, MD     Leicester Royal Infirmary    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067452, LRI-IND.02-V3, EU-99036
First Received:   January 21, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004206
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Leucovorin
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Oxaliplatin
Fluorouracil
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on November 30, 2008




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