Sunitinib Malate in Refractory Germ Cell Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00912912
First received: June 1, 2009
Last updated: April 24, 2013
Last verified: April 2013
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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 2014 (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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Progressive metastatic GCTs of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.
- 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.
- ECOG Performance Score 0-2
- 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.
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade </= 2.
- At least 18 years of age as safety of sunitinib in a pediatric population has not been established.
- Able to provide informed consent
- Must be able to ingest oral medication
- 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.
- 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:
- NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.
- 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.
- Patients with history of Long QT syndrome.
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.
- Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- Symptomatic bowel obstruction.
- Prior VEGFR/PDGFR inhibitor therapy.
- Known human immunodeficiency virus infection, chronic active hepatitis or liver cirrhosis.
Contacts and Locations
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 |
| Study First Received: | June 1, 2009 |
| Last Updated: | April 24, 2013 |
| 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 Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Sunitinib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013