Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy. Determine the nature and degree of toxicity of this treatment regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.

Official Title
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Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment Clinically and/or histologically confirmed persistent or recurrent disease Measurable disease by physical examination or medical imaging Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable Ascites or pleural effusions not considered measurable Must have received 1 prior cytotoxic therapy regimen May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment 1 additional noncytotoxic regimen allowed Biologic or cytostatic agents include, but are not limited to: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction Ineligible for a higher priority GOG protocol No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-2 if received 1 prior therapy regimen GOG 0-1 if received 2 prior therapy regimens Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Cardiovascular No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Neurologic No sensory or motor neuropathy greater than grade 1 No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergy to platinum compounds or antiemetics No active infection requiring antibiotics No other uncontrolled illness No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 14 days since prior pegfilgrastim At least 24 hours since other prior growth factors At least 3 weeks since prior biologic or immunologic therapy No concurrent growth factors during first course of study therapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy No prior oxaliplatin Endocrine therapy At least 1 week since prior hormonal therapy directed at tumor Concurrent hormone replacement therapy allowed Radiotherapy At least 4 weeks since prior radiotherapy and recovered Surgery Recovered from any recent surgery Other At least 3 weeks since prior therapy for endometrial cancer No other concurrent investigational agents No prior anticancer therapy that would preclude study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent endometrial carcinoma