Mode
Text Size
Log in / Sign up
Phase 2 N=10 Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search