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Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -

Phase 2
18 Years
Not Enrolling
Relapsed or Cisplatin-Refractory Germ Cell Cancer

Thank you

Trial Information

Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -

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 approved for standard treatment. SU011248 inhibits enzymes (chemicals that
help cells function) called tyrosine kinases, which are important enzymes for tumor growth
and tumor spread in your body. If these enzymes are blocked, tumor growth may be disrupted
and subsequently the cancer cell may die. SU011248 has been given to patients with kidney
cancer and other cancers in clinical trials and some of them have improved, although it is
not yet certain how often this occurs. There is some evidence that the enzymes inhibited by
SU011248 also play an important role in the development and growth of germ cell cancers.
This is the reason why SU011248 is being tested in subjects with germ cell cancers.



To assess the response rate of SU011248 in patients with relapsed or cisplatin- refractory
germ cell cancer.

Secondary: To assess the rate of disease stabilizations, toxicity, time to progression and
response duration of SU011248 given to patients with relapsed or cisplatin-refractory germ
cell cancer.

Study Drug Regimen:

SU011248 will be given at 50 mg once daily for 4 consecutive weeks followed by a 2-week rest
period to comprise a complete cycle of 6 weeks. SU011248 will be orally self-administered
once daily without regard to meals. Patients will remain on the study drug until disease

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Principal Investigator

Christian K Kollmannsberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency -Vancouver Centre


Canada: Health Canada

Study ID:

Testis protocol Version 003



Start Date:

November 2006

Completion Date:

June 2009

Related Keywords:

  • Relapsed or Cisplatin-Refractory Germ Cell Cancer
  • relapsed or cisplatin-refractory germ cell cancer
  • germ cell cancer
  • SU011248 (Sunitinib)
  • Neoplasms, Germ Cell and Embryonal