COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071929
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: oxaliplatin Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date : November 1999
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 arrhythmia


  • 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 cancer


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071929

Show Show 38 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00071929    
Other Study ID Numbers: CDR0000068235
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: September 2004
Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents