Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI GOG-0129K NCT00071929

Objectives

1. 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.
2. Determine the nature and degree of toxicity of this treatment regimen in these patients.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 19-51 patients will be accrued for this study.

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.

Fracasso PM, Blessing JA, Molpus KL, et al.: Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 103 (2): 523-6, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Paula Fracasso, MD, PhD, Protocol chair		Ph: 314-454-8817; 800-600-3606

Registry Information
Official Title		Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Trial Start Date		1999-11-15
Registered in ClinicalTrials.gov		NCT00071929
Date Submitted to PDQ		2000-08-24
Information Last Verified		2004-09-10
NCI Grant/Contract Number		CA27469

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