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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer



Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

For Condition: recurrent endometrial cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use 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 recurrentendometrial cancer.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 - Any age 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulaFracasso,  Study Chair,  Washington University School of Medicine

Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Kenneth  Cofer 865-673-9250

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

Abington Memorial Hospital *Recruiting*
Abington,  Pennsylvania,  19001-3788
United States
Recruiting Parviz  Hanjani 215-885-0220

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Robert  Burger 714-456-7971

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7357
United States
Recruiting Julia  Chapman 913-588-6225

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Sara  Crowder 573-882-1057

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Nava  Siegelmann-Danieli 570-271-6834

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

New Britain General Hospital *Recruiting*
New Britain,  Connecticut,  06052
United States
Recruiting James  Hoffman 860-826-1101

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62794-9640
United States
Recruiting L.  Massad 217-545-8882

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anthony  Evans 715-389-3101

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111
United States
Recruiting Michael  Bookman 215-728-2987

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

Magee-Womens Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15213-3180
United States
Recruiting Joseph  Kelley 412-641-5418

Saint Joseph Regional Medical Center *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Michael  Method 574-237-8010

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

Mount Carmel West Hospital *Recruiting*
Columbus,  Ohio,  43222
United States
Recruiting Luis  Vaccarello 614-224-7662

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting George  Olt 717-531-8144

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-2516
United States
Recruiting Marta  Crispens 615-322-2114

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364


Additional Information:
Study ID Numbers:
  CDR0000068235;  GOG-0129K
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071929

Other Recurrent Endometrial Cancer Studies:
1. Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer

2. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer

3. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer

4. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

5. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

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