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Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

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Trial Information

Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma


- 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

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.

Inclusion Criteria


- 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



- 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


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN


- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac


- 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)


- 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


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


- 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


- At least 4 weeks since prior radiotherapy and recovered


- Recovered from any recent surgery


- At least 3 weeks since prior therapy for endometrial cancer

- No other concurrent investigational agents

- No prior anticancer therapy that would preclude study participation

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

September 2007

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
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CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Evanston Evanston, Illinois  60201
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
SUNY Downstate Medical Center Brooklyn, New York  11203
New Britain General Hospital New Britain, Connecticut  06050
Mount Carmel West Hospital Columbus, Ohio  43222
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