oxaliplatin in treating patients with persistent or recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: 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.

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.

Eligibility criteria:
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

Keywords: recurrent endometrial carcinoma