Sunitinib Malate in Refractory Germ Cell Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00912912
First received: June 1, 2009
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.


Condition Intervention Phase
Genitourinary Disease
Drug: Sunitinib Malate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: June 2009
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib Malate
Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Drug: Sunitinib Malate
50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Other Names:
  • SU011248
  • Sutent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Progressive metastatic GCTs of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.
  2. Must have evaluable or measurable disease by clinical or radiological studies. Alternatively, in the absence of radiologically evaluable or measurable disease, two sequentially rising marker values each one week apart attributed by treating physician to germ cell tumor is permitted; either beta HCG above 50 mIU/ml and/or AFP above 20 ng/ml qualifies as eligible.
  3. ECOG Performance Score 0-2
  4. Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min, Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12 mg/dL, Platelet count >/= 75,000/mm^3, AST/ALT < 2.5 x ULN, Total bilirubin < 2.0mg/dl.
  5. Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade </= 2.
  6. At least 18 years of age as safety of sunitinib in a pediatric population has not been established.
  7. Able to provide informed consent
  8. Must be able to ingest oral medication
  9. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  10. Patients who have not received prior high-dose chemotherapy and stem cell rescue as salvage therapy will have this option discussed with them. Only patients ineligible, unwilling or unable to undertake this option will be eligible for this trial.

Exclusion Criteria:

  1. NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.
  2. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  3. Patients with history of Long QT syndrome.
  4. Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.
  5. Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).
  6. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
  7. Symptomatic bowel obstruction.
  8. Prior VEGFR/PDGFR inhibitor therapy.
  9. Known human immunodeficiency virus infection, chronic active hepatitis or liver cirrhosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912912

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Study Chair: Lance Pagliaro, MD, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00912912     History of Changes
Other Study ID Numbers: 2006-0685, NCI-2012-01645
Study First Received: June 1, 2009
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Genitourinary
Testis
Refractory Germ Cell Tumors
Advanced germ cell tumors
GCTs
Sunitinib Malate
Sutent
SU011248

Additional relevant MeSH terms:
Urologic Diseases
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014