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A Phase II Evaluation Of Gleevecâ„¢ (NCI-Supplied Agent: STI571 [Imatinib Mesylate], IND #61135, NSC #716051) In The Treatment Of Recurrent Or Persistent Carcinosarcoma Of The Uterus


Phase 2
N/A
N/A
Not Enrolling
Female
Recurrent Uterine Sarcoma, Uterine Carcinosarcoma

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Trial Information

A Phase II Evaluation Of Gleevecâ„¢ (NCI-Supplied Agent: STI571 [Imatinib Mesylate], IND #61135, NSC #716051) In The Treatment Of Recurrent Or Persistent Carcinosarcoma Of The Uterus


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Warner Huh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02565

NCT ID:

NCT00075400

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103