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Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Carcinosarcoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Gynecologic Oncology Group
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

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
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

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

  Show 62 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Warner Huh, MD Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000346361, GOG-0230C
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075400  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Imatinib
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Uterine sarcoma
Soft tissue sarcomas
Recurrence
Carcinosarcoma

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

ClinicalTrials.gov processed this record on January 16, 2009