Status:
COMPLETED
Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Canadian Urologic Oncology Group
NCIC Testis Group
Conditions:
Relapsed or Cisplatin-Refractory Germ Cell Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 in...
Detailed Description
SU011248 is a new investigational drug that has been shown to be effective against kidney cancer and other cancers in clinical trials. An investigational drug in Canada is a drug that is not yet appro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00371553
Start Date
November 1 2006
End Date
June 1 2009
Last Update
July 8 2009
Active Locations (6)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T4N 4N2
2
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
QEII Health Science Center
Halifax, Nova Scotia, Canada, B3H 2Y9