Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071929
• Other study ID #: CDR0000068235
• Secondary ID: GOG-0129K
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: June 20, 2013
• Start date: November 1999
• Est. completion date: September 2007

Study information

• Verified date: September 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• oxaliplatin

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	New Britain General Hospital	New Britain	Connecticut
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. Epub 2006 May 19. — View Citation