Status:
COMPLETED
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Pfizer
Conditions:
Extragonadal Germ Cell Tumor
Ovarian Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 we...
Detailed 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 patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00453310
Start Date
March 1 2007
End Date
November 1 2008
Last Update
October 27 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021