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Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Carcinosarcoma
This study is ongoing, but not recruiting participants.
First Received: January 9, 2004   Last Updated: May 30, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075400
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent or persistent uterine carcinosarcoma.


Condition Intervention Phase
Sarcoma
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Gleevec™ (NCI-Supplied Agent: STI571 [Imatinib Mesylate], IND #61135, NSC #716051) In The Treatment Of Recurrent Or Persistent Carcinosarcoma Of The Uterus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  • Clinical response (partial and complete) as assessed by RECIST [ Designated as safety issue: No ]
  • Prognostic factors (initial performance status and histological grade) [ Designated as safety issue: No ]

Study Start Date: January 2004
Estimated Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with recurrent or persistent uterine carcinosarcoma.
  • Determine the frequency and severity of adverse effects of this drug in these patients.

Secondary

  • Determine the distribution of overall and progression-free survival in patients treated with this drug.
  • Determine the objective response rate (partial and complete response) in patients treated with this drug.
  • Determine the effects of this drug on prognostic factors (initial performance status and histological grade) in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days 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: A total of 19-51 patients will be accrued for this study within 15-30 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine carcinosarcoma

    • Malignant mixed Mullerian tumor, homologous or heterologous type
    • Persistent or recurrent disease
  • Progressive disease after prior local therapy
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Presence of at least 1 target lesion (to be used to assess response)

    • Tumors within a previously irradiated field are considered non-target lesions
  • Received 1 prior chemotherapy regimen for carcinosarcoma

    • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • One additional prior cytotoxic regimen for recurrent or persistent disease allowed
  • Ineligible for a higher priority GOG protocol
  • No clinically apparent CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • GOG 0-2 (for patients who have received 1 prior regimen) OR
  • GOG 0-1 (for patients who have received 2 prior 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 deep venous or arterial thrombosis within the past 6 weeks
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring therapy

Pulmonary

  • No pulmonary embolism within the past 6 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No history of seizures
  • No sensory or motor neuropathy greater than grade 1
  • No signs or symptoms of bowel dysfunction or obstruction
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No active or uncontrolled infection requiring antibiotics
  • No other concurrent severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior immunologic agents directed at the malignant tumor
  • No concurrent biologic agents directed at the malignant tumor
  • No concurrent prophylactic growth factors
  • No concurrent prophylactic thrombopoietic agents

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • No concurrent chemotherapy directed at the malignant tumor

Endocrine therapy

  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • Concurrent hormone replacement therapy allowed
  • No concurrent therapeutic corticosteroids

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy directed at the malignant tumor
  • No prior imatinib mesylate
  • No prior cancer treatment that would contraindicate study therapy
  • No concurrent therapeutic anticoagulation with warfarin
  • No concurrent amifostine or other protective agents
  • No concurrent phenytoin, phenobarbital, or carbamazepine
  • No other concurrent therapy directed at the malignant tumor
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075400

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Banner Thunderbird Medical Center
Phoenix, Arizona, United States, 85306
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
United States, Colorado
Colorado Gynecologic Oncology Group P.C.
Denver, Colorado, United States, 80218
McKee Medical Center
Loveland, Colorado, United States, 80539
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Gynecologic Oncology
Englewood, Colorado, United States, 80110
United States, Connecticut
New Britain General Hospital
New Britain, Connecticut, United States, 06050
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Rush University Medical Center
Chicago, Illinois, United States, 60612
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48202
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States, 08103
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
United States, New York
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19612
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Warner Huh, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000346361, GOG-0230C
Study First Received: January 9, 2004
Last Updated: May 30, 2009
ClinicalTrials.gov Identifier: NCT00075400     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
uterine carcinosarcoma
recurrent uterine sarcoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Complex and Mixed
Carcinosarcoma

ClinicalTrials.gov processed this record on November 25, 2009