Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

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