Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00071929

GOG-0129K

CDR0000068235

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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