Status:
UNKNOWN
Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Lead Sponsor:
Fondation Wygrajmy Zdrowie
Conditions:
Testicular Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur most frequently in testis. The incidence is about 1%, but is increasing in the majority of developed count...
Eligibility Criteria
Inclusion
- Male patients \> 18 years of age
- Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
- Patients must have the disease not amendable to cure with either surgery or chemotherapy
- Patients must have failed at least two cisplatin-based combination chemotherapy regimens.
- Failure on prior regimens will be defined as either:
- A ≥ 25% increase in sum of target lesions, new lesions, or
- An increasing AFP or HCG above the nadir level.
- Patients with at least one measurable lesion by CT scan or MRI according to RECIST criteria
- Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits: WBC \> 2.0 x 109/l and platelets \> 60 x 109/l, total bilirubin \< 2 x upper limit, AST and ALT \< 5 x upper limit normal, serum creatinine \< 2 x UNL
- WHO Performance Status 0, 1, 2
- No concurrent chemotherapy or radiotherapy
- Life expectancy of at least 12 weeks
- Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- A signed informed consent must be obtained prior to any study specific procedures
- All patients must agree to use adequate contraception during the whole study period
Exclusion
- Patients not fulfilling of inclusion criteria
- Primary radiotherapy in the field of target lesion
- Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
- Known serious and active bacterial, viral or fungal infection (\> grade II CTC-AE) including HBV, HCV and HIV carrier state.
- Previous or concurrent malignancy except for basal cell carcinoma of the skin
- Uncontrolled hypertension.
- Thrombotic or embolic event in last 6 months prior to inclusion.
- Impairment of gastrointestinal tract, or GI disease that may influence the bioavailability of oral sorafenib
- Substance and alcohol abuse (nicotine use is allowed)
- Known or suspected hypersensitivity to sorafenib.
- Participants in any other clinical trial using investigational drug within 4 weeks prior to study entry
- Prior use of investigational or licensed angiogenesis and RAF kinase or MEK inhibitors.
- Patient unwilling or unable to give informed consent
- Any condition that may in the investigator's opinion jeopardize the safety of the patient or his compliance in the study.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00772694
Start Date
September 1 2008
End Date
December 1 2011
Last Update
October 24 2008
Active Locations (1)
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1
Chemotherapy Unit, Dept of Urology, Instituite of Oncology
Warsaw, Poland, 02781