Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00071929
First received: November 4, 2003
Last updated: June 20, 2013
Last verified: September 2004
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Study Completion Date: September 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071929

  Show 38 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00071929     History of Changes
Other Study ID Numbers: CDR0000068235, GOG-0129K
Study First Received: November 4, 2003
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014