Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

Completed · Phase 2

Conditions studied: Recurrent Uterine Sarcoma, Uterine Carcinosarcoma

In brief

This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT00075400
Run by: National Cancer Institute (NCI)
People needed: 26
Starts: 2004-01-01
Expected to finish: 2010-07-01
Last updated by the study team: 2019-07-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed uterine carcinosarcoma that is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed Mullerian tumor), homologous or heterologous type
All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions
Patients must not be eligible for a higher priority Gynecological Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
Patients should be free of active infection requiring antibiotics
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE v3.0 grade 1
Platelets greater than or equal to 100,000/mcl
Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients who have met the pre-entry requirements
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception, and cannot be lactating; since interactions with the metabolism of oral contraceptives cannot be excluded, a barrier method of contraception must be used
Patients must have tissue blocks from initial diagnosis available for submission to the GOG Tissue Bank

You may not qualify if…

Patients who had previous treatment with Gleevec\^TM
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
Patients with signs or symptoms of bowel dysfunction or obstruction
Patients receiving therapeutic anticoagulation with warfarin
Patients with deep venous or arterial thrombosis (including pulmonary embolism) within six weeks of study entry
Patients receiving therapeutic corticosteroids
Patients with active or uncontrolled infection
History of seizures or those patients receiving phenytoin, phenobarbital, or carbamazepine
Patients with other severe concurrent disease, which the investigator feels may make the patients inappropriate for study entry
Presence of clinically apparent central nervous system metastases, or other carcinomatous meningitis
History of myocardial infarction within previous six months or congestive heart failure requiring therapy

Where it is running

Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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