germ cell cancer MedDRA version: 8.1 Level: LLT Classification code 10061378 Term: Testicular germ cell cancer
Conditions
Interventions
Trade Name: SUTENT 50 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: SUTENT 1
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Germany
Outcome results
None listed