Prospective open-labeled non randomized Phase-II study of SU011248 (Sunitinib) in male patients with relapsed or cisplatin-refractory germ cell cancer - A CUOG/GTCSG cooperative phase II study

Active, not recruiting

• Conditions: germ cell cancer; MedDRA version: 8.1Level: LLTClassification code 10061378Term: Testicular germ cell cancer

• Registration Number: EUCTR2006-004667-61-DE
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

•Male Patients with histologically proven seminomatous or non-seminomatous germ cell cancer and
relapse within 8 weeks after at least 2 different cisplatin-based regimens and not eligible for high-dose setting therapy or
disease progression or relapse after salvage high-dose chemotherapy or
disease progression during cisplatin-based chemotherapy and
contraindications for aggressive chemotherapy and failure of alternative off label drugs e.g. gemcitabine, oxaliplatin, paclitaxel.
•Concurrent radiation therapy is permitted if the radiated lesion is NOT the only measurable lesion
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan Or, tumor marker increase > 25% within 4 weeks.
• Life expectancy of greater than 3 months
•Karnofsky Performance status ? 60 (appendix 1)
•18 years of age or older.
•Adequate bone marrow function defined as follows:
-Neutrophils > 1500/µl,
-Thrombocytes > 100 000/µl
•Adequate organ function defined as follows:
-Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT])
and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT])
= 2.5 x upper limit of normal or AST and ALT = 5 x , if liver function abnormalities are due to underlying malignancy
-Creatinine = 2 x upper limit normal (ULN)
-Prothrombin time (PT) or International normalized ratio (INR) =1.5 x ULN
-Bilirubin < 1.5 x ULN
•Resolution of acute toxic effects of prior radiotherapy, surgical procedure or chemotherapy to NCI CTCAE Version 3.0 = grade 1.
•Adequate heart function and 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 indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
•Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
•Contraception: Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Acute infection
•Uncontrolled intercurrent illness including, but not limited to, active peptic ulcer, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Patients with a history of other active malignancy in the past 5 years (with the exception of 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 on full dose warfarin are excluded. Patients are permitted if they are on low molecular weight heparin or prophylactic anticoagulation (ie. Low dose warfarin) of venous or arterial access devices, provided that the requirements for PT and/or INR are met.
•Major surgery or radiation therapy within < 4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
•Patients with treated brain metastases which are clinically and radiologically stable for at least 6 months are permitted. Patients with unstable brain metastases spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan are excluded.
•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; thyroid function measured by Thyroxine (T4), T-Uptake (T3), and Thyroid Stimulating Hormone (TSH) levels.
• 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.
•Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the response rate of SU011248 in patients with relapsed or cisplatin-refractory germ cell cancer.;Secondary Objective: 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.;Primary end point(s): To determine the antitumor activity of SU011248 in relapsed or cisplatin-refractory germ cell cancer using objective tumor response rate (defined as partial or completed response by RECIST criteria).