Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborators: Canadian Urologic Oncology Group; German Testicular Cancer Study Group; NCIC Testis Group
• Treatments: Cisplatin; Sunitinib

Criteria

Inclusion Criteria:

• patients with histologically proven seminomatous or non-seminomatous germ cell cancer

• patients with relapse within 8 weeks after at least 2 different cisplatin- based regimens or

• patients with disease progression or relapse after salvage high-dose chemotherapy or patients with disease progression during cisplatin-based chemotherapy or patients with contraindications for other aggressive chemotherapy

• measurable disease

• Life expectancy of greater than 3 months

• Karnofsky Performance status > 60

• age > 18

• adequate organ function

• Resolution of acute toxic effects of prior radiotherapy, surgical procedure or chemotherapy to NCI CTCAE Version 3.0 <= grade 1.

• Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan or echocardiography

• Signed and dated informed consent document

• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

• Acute infection

• Uncontrolled intercurrent illness

• Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non melanomatous skin cancers) are excluded.

• Interval from last chemotherapy < 3 weeks.

• Simultaneous radiation of the only target lesion

• NCI CTCAE grade 3 hemorrhage < 4 weeks of starting the study treatment

• Patients must not be on therapeutic anticoagulation.

• Major surgery or radiation therapy within < 4 weeks of starting the study treatment.

• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease

• 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.

• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

• Ongoing cardiac arrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >500 msec on baseline EKG.

• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

• Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).

• Current treatment on another clinical trial.