Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Carcinosarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	GOG-0230C NCT00075400

Objectives

Primary

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

Secondary

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

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 19-51 patients will be accrued for this study within 15-30 months.

Outcomes

Progression-free survival at 6 months
Frequency and severity of adverse effects as assessed by NCI CTCAE v3.0

Duration of progression-free survival and overall survival
Clinical response (partial and complete) as assessed by RECIST
Prognostic factors (initial performance status and histological grade)

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Warner Huh, MD, Protocol chair		Ph: 205-934-4986; 800-822-0933 Email: whuh@uab.edu

Registry Information
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
Trial Start Date		2004-01-05
Trial Completion Date		2006-02-08 (estimated)
Registered in ClinicalTrials.gov		NCT00075400
Date Submitted to PDQ		2003-11-12
Information Last Verified		2005-06-15
NCI Grant/Contract Number		CA27469

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