Sunitinib Malate in Refractory Germ Cell Tumors

NCT00912912 | Terminated Phase 2 Results

• 2 other identifiers: 2006-0685NCI-2012-01645
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genitourinary Disease

Keywords

Genitourinary; Testis; Refractory Germ Cell Tumors; Advanced germ cell tumors; GCTs; Sunitinib Malate; Sutent; SU011248

Outcome Measures

Primary Outcomes (1)

• 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate

  Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

  12 weeks

Study Arms (1)

Sunitinib Malate

EXPERIMENTAL

Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

Drug: Sunitinib Malate

Interventions

Sunitinib Malate DRUG

50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

Also known as: SU011248, Sutent

Sunitinib Malate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Progressive metastatic Germ-cell tumors (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 human chorionic gonadotropin (hCG) above 50 mIU/ml and/or alpha-fetoprotein (AFP) above 20 ng/ml qualifies as eligible.
• The Eastern Cooperative Oncology Group (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 (SGOT)/ALT (SGPT) \< 2.5 x upper limit of normal (ULN), Total bilirubin \< 2.0mg/dl.
• Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI Common Terminology Criteria for Adverse Events (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Subbiah V, Meric-Bernstam F, Mills GB, Shaw KR, Bailey AM, Rao P, Ward JF, Pagliaro LC. Next generation sequencing analysis of platinum refractory advanced germ cell tumor sensitive to Sunitinib (Sutent(R)) a VEGFR2/PDGFRbeta/c-kit/ FLT3/RET/CSF1R inhibitor in a phase II trial. J Hematol Oncol. 2014 Aug 1;7:52. doi: 10.1186/s13045-014-0052-x.

  PMID: 25085632 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Urogenital Diseases; Neoplasms, Germ Cell and Embryonal

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Lance Pagliaro, MD/Genitourinary Medical Oncology
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Lance Pagliaro, MD, BA

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 15, 2016
• Results First Posted: January 27, 2016

Record last verified: 2016-03

Locations

US (1)