The MRS study
- Conditions
- Testicular cancerCancer
- Registration Number
- ISRCTN56178790
- Lead Sponsor
- Prof. Grzegorz Madej Memorial Foundation Win the health (Fundacja Wygrajmy Zdrowie im Prof. Grzegorza Madeja) (Poland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 20
1. Male patients greater than 18 years of age
2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
3. Patients must have the disease not amendable to cure with either surgery or chemotherapy
4. Patients must have failed at least two cisplatin-based combination chemotherapy regimens
5. Failure on prior regimens will be defined as either:
5.1. A greater than or equal to 25% increase in sum of target lesions, new lesions, or
5.2. An increasing Alpha Fetoprotein (AFP) or Human Chorionic Gonadotropin (HCG) above the nadir level
6. Patients with at least one measurable lesion by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria
7. Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits:
7.1. White Blood Cells (WBC) greater than 2.0 x 10^9/l and platelets greater than 60 x 10^9/l
7.2. Total bilirubin less than 2 x Upper Limit of Normal (ULN)
7.3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 5 x ULN
7.4. Serum creatinine less than 2 x ULN
8. World Health Organization (WHO) performance status 0, 1, 2
9. No concurrent chemotherapy or radiotherapy
10. Life expectancy of at least 12 weeks
11. Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
12. A signed informed consent must be obtained prior to any study specific procedures
13. All patients must agree to use adequate contraception during the whole study period
1. Patients not fulfilling of inclusion criteria
2. Primary radiotherapy in the field of target lesion
3. Major surgery (Retroperitoneal Lymph Node Dissection [RPLND]) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
4. Known serious and active bacterial, viral or fungal infection (greater than grade II Common Terminology Criteria for Adverse Events [CTC-AE]) including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) carrier state
5. Previous or concurrent malignancy except for basal cell carcinoma of the skin
6. Uncontrolled hypertension
7. Thrombotic or embolic event in last 6 months prior to inclusion
8. Impairment of Gastrointestinal (GI) tract, or GI disease that may influence the bioavailability of oral sorafenib
9. Substance and alcohol abuse (nicotine use is allowed)
10. Known or suspected hypersensitivity to sorafenib
11. Participance in any other clinical trial using investigational drug within 4 weeks prior to study entry
12. Prior use of investigational or licensed angiogenesis and Raf kinase or Mitogen-activated Extracellular-signal-Regulated Kinase (ERK) (MEK) inhibitors
13. Patient unwilling or unable to give informed consent
14. Any condition that may in the investigator?s opinion jeopardize the safety of the patient or his compliance in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method 1. Overall Relapse Rate (ORR)<br>2. Overall Survival (OS)<br>3. Toxicity<br>4. Evaluation of panel of biomarkers, will be assessed every 4 weeks<br>5. Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] version 3.0 pol and testicular cancer module), will be assessed every 12 weeks