Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Data Collection
Urogenital Diseases+9
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 38 locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesSee the locationCCOP - Western Regional, Arizona
Phoenix, United StatesChao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, United StatesUniversity of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, United States