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

Primary Purpose

Relapsed or Cisplatin-Refractory Germ Cell Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SU011248 (Sunitinib)
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Cisplatin-Refractory Germ Cell Cancer focused on measuring relapsed or cisplatin-refractory germ cell cancer, germ cell cancer, SU011248 (Sunitinib)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tom Baker Cancer Centre
  • BC Cancer Agency - Vancouver Centre
  • Cancer Care Manitoba
  • QEII Health Science Center
  • London Regional Cancer Centre
  • Princess Margaret Hospital

Outcomes

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

Full Information

First Posted
September 1, 2006
Last Updated
July 7, 2009
Sponsor
British Columbia Cancer Agency
Collaborators
Canadian Urologic Oncology Group, NCIC Testis Group, German Testicular Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00371553
Brief Title
Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
British Columbia Cancer Agency
Collaborators
Canadian Urologic Oncology Group, NCIC Testis Group, German Testicular Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 increase disease response.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Cisplatin-Refractory Germ Cell Cancer
Keywords
relapsed or cisplatin-refractory germ cell cancer, germ cell cancer, SU011248 (Sunitinib)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SU011248 (Sunitinib)
Primary Outcome Measure Information:
Title
Response Rate
Secondary Outcome Measure Information:
Title
Rate and duration of stable disease
Title
Time to progression.
Title
Median and 1 yr survival
Title
Safety and tolerability of SU011248

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian K Kollmannsberger, MD
Organizational Affiliation
BC Cancer Agency -Vancouver Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T4N 4N2
Country
Canada
Facility Name
BC Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
QEII Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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