Phase 2
N=10
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Extragonadal Germ Cell Tumor · Ovarian Cancer · Teratoma · Testicular Germ Cell Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00453310 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Oct 2015
Primary outcome: Primary: Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment — 3; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sunitinib malate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment |
3; 7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00453310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.