Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT00071929 | Completed Phase 2

• 2 other identifiers: CDR0000068235GOG-0129K
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 38

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.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma

Interventions

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (38)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06052, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62794-9640, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11790-7775, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44124, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Southeast Gynecologic Oncology Associates

Knoxville, Tennessee, 37917, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Related 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. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.

  PMID: 16712905 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Paula M. Fracasso, MD, PhD

  Washington University Siteman Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: November 1, 1999
• Study Completion: September 1, 2007
• Last Updated: June 24, 2013

Record last verified: 2004-09

Locations

US (38)