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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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