Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Carcinosarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075400
First received: January 9, 2004
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent or persistent uterine carcinosarcoma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth


Condition Intervention Phase
Recurrent Uterine Sarcoma
Uterine Carcinosarcoma
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Severity of adverse effects as assessed by NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Compared using a logrank test and a Cox proportional hazards model while adjusting for initial performance status and histological grade.

  • Overall survival [ Time Frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Compared using a logrank test and a Cox proportional hazards model while adjusting for initial performance status and histological grade.

  • Clinical response (partial and complete) as assessed by RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: January 2004
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
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.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with recurrent or persistent uterine carcinosarcoma.

II. Determine the frequency and severity of adverse effects of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the distribution of overall and progression-free survival in patients treated with this drug.

II. Determine the objective response rate (partial and complete response) in patients treated with this drug.

III. 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.

  Eligibility

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

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2 (for patients who have received 1 prior regimen)
  • Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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
  • Creatinine no greater than 1.5 times ULN
  • 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
  • No pulmonary embolism within the past 6 weeks
  • 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
  • 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
  • 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
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • Concurrent hormone replacement therapy allowed
  • No concurrent therapeutic corticosteroids
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • Recovered from prior surgery
  • 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

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Warner Huh Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075400     History of Changes
Other Study ID Numbers: NCI-2012-02565, GOG-0230C, U10CA027469, CDR0000346361
Study First Received: January 9, 2004
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013