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

Sponsors and Collaborators:	British Columbia Cancer Agency Canadian Urologic Oncology Group NCIC Testis Group German Testicular Cancer Study Group (GTSCG)
Information provided by:	British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT00371553

Purpose

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.

Condition	Intervention	Phase
Relapsed or Cisplatin-Refractory Germ Cell Cancer	Drug: SU011248 (Sunitinib)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	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 -

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:

Response Rate

Secondary Outcome Measures:

Rate and duration of stable disease
Time to progression.
Median and 1 yr survival
Safety and tolerability of SU011248

Enrollment:	33
Study Start Date:	November 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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 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.

Objectives:

Primary:

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 progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371553

Locations

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T4N 4N2
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Science Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6

Sponsors and Collaborators

British Columbia Cancer Agency

Canadian Urologic Oncology Group

NCIC Testis Group

German Testicular Cancer Study Group (GTSCG)

Investigators

Principal Investigator:

Christian K Kollmannsberger, MD

BC Cancer Agency -Vancouver Centre

More Information

No publications provided

Responsible Party:	BC Cancer Agency ( Dr Christian Kollmannsberger )
Study ID Numbers:	Testis protocol Version 003, CUOG-TE 05/OZM-007
Study First Received:	September 1, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00371553 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:

relapsed or cisplatin-refractory germ cell cancer
germ cell cancer
SU011248 (Sunitinib)

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Sunitinib

Neoplasms, Germ Cell and Embryonal
Malignant Germ Cell Tumor
Angiogenesis Inhibitors

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms

Cisplatin
Radiation-Sensitizing Agents
Sunitinib
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on September 09, 2009