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Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • CCOP - Western Regional, Arizona
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • New Britain General Hospital
  • CCOP - Christiana Care Health Services
  • MBCCOP - University of Illinois at Chicago
  • University of Chicago Cancer Research Center
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Carle Cancer Center
  • Saint Joseph Regional Medical Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Grand Rapids
  • CCOP - Kalamazoo
  • CCOP - Metro-Minnesota
  • University of Mississippi Medical Center
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Missouri Valley Cancer Consortium
  • SUNY Downstate Medical Center
  • Long Island Cancer Center at Stony Brook University Hospital
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Mount Carmel West Hospital
  • University of Oklahoma College of Medicine
  • CCOP - Columbia River Oncology Program
  • Abington Memorial Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Fox Chase Cancer Center
  • Magee-Womens Hospital
  • Southeast Gynecologic Oncology Associates
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • CCOP - Scott and White Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
June 20, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00071929
Brief Title
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title
Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2004
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula M. Fracasso, MD, PhD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62794-9640
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3180
Country
United States
Facility Name
Southeast Gynecologic Oncology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2516
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16712905
Citation
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. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.
Results Reference
result

Learn more about this trial

Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

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