Ovarian Cancer Clinical Trial
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
Full Description
OBJECTIVES:
Primary
Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
Secondary
Determine the safety of this drug in these patients.
Determine the time to tumor response and duration of tumor response in patients treated with this drug.
OUTLINE: This is a open-label study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 28 days and then periodically thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT)
Refractory or relapsed disease
Metastatic disease
Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy:
Not a candidate for potentially curative therapy
Received prior high-dose chemotherapy regimens
Declines potentially curative therapy (mediastinal GCT or primary refractory GCT)
Measurable disease*, defined as 1 of the following:
At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Elevation of alpha-fetoprotein > 15 ng/mL and/or elevation of human chorionic gonadotropin > 2.2 mIU/L
NOTE: *Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy)
LVEF ≥ 50% by MUGA
No grade 3 hemorrhage within the past 4 weeks
None of the following within the past 6 months:
Myocardial infarction
Severe or unstable angina
Coronary or peripheral artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident or transient ischemic attack
Pulmonary embolism
No prolonged QTc interval (i.e., QTc > 450 msec for males and > 470 msec for females)
No ongoing cardiac dysrhythmias ≥ grade 2
No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal therapy
No active infection
No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance, according to the study investigator
Not pregnant or nursing
Negative sonogram required to exclude pregnancy
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior sunitinib malate
More than 4 weeks since prior major surgery and recovered
More than 4 weeks since prior radiotherapy and recovered
Concurrent palliative radiotherapy to metastatic lesion(s) allowed provided ≥ 1 measurable lesion has not been irradiated
No concurrent therapeutic doses of warfarin
Low-dose oral warfarin (up to 2 mg daily) for prophylaxis and treatment or heparin products at prophylactic or treatment doses allowed
No other concurrent investigational or approved anticancer therapies, including chemotherapy, biologic response modifiers, hormone therapy, or immunologic-based treatment
Concurrent participation in supportive care or nontreatment trials (e.g., quality-of-life or laboratory analyses) allowed
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There is 1 Location for this study
New York New York, 10021, United States
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