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Status:

COMPLETED

Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Endometrial Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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...

Detailed 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 th...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 1999

    Trial Type :

    INTERVENTIONAL

    End Date :

    September 1 2007

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00071929

    Start Date

    November 1 1999

    End Date

    September 1 2007

    Last Update

    June 24 2013

    Active Locations (38)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (38 locations)

    1

    University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294-3300

    2

    CCOP - Western Regional, Arizona

    Phoenix, Arizona, United States, 85006-2726

    3

    Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, United States, 92868

    4

    University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, United States, 80010