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

NCT00371553 | Completed Phase 2 DMC

• 2 other identifiers: Testis protocol Version 003CUOG-TE 05/OZM-007
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

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.

Conditions

Relapsed or Cisplatin-Refractory Germ Cell Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

Secondary Outcomes (4)

• Rate and duration of stable disease

• Time to progression.

• Median and 1 yr survival

• Safety and tolerability of SU011248

Interventions

SU011248 (Sunitinib) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Urologic Oncology Group: collaborator
• NCIC Testis Group: collaborator
• German Testicular Cancer Study Group: collaborator

Study Sites (6)

Tom Baker Cancer Centre

Calgary, Alberta, T4N 4N2, Canada

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Science Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Recurrence; Neoplasms, Germ Cell and Embryonal

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christian K Kollmannsberger, MD

  BC Cancer Agency -Vancouver Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 4, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

CA (6)