Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

NCT00453310

Last updated date
Study Location
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-120 years

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Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell TumorSunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
NCT00453310
  1. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Official Title  ICMJE A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
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 well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE Drug: sunitinib malate
Study Arms  ICMJE Experimental: sunitinib malate
The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
Intervention: Drug: sunitinib malate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2013)
10
Original Enrollment  ICMJE
 (submitted: March 27, 2007)
29
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453310
Other Study ID Numbers  ICMJE 07-004
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Dean F. Bajorin, MDMemorial Sloan Kettering Cancer Center
Principal Investigator:Robert J. Motzer, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP