Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
GCT
Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
3 other identifiers
interventional
20
1 country
1
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 countries. The testicular cancer is an extremely important oncological condition due to his high rate of 80-90% of curability, which can be achieved by combination of chemotherapy and surgery. Some of 20-30% of patients will experience disease progression after first line cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage chemotherapy will result in long term remissions in \< 50% of patients (VeIP - vinblastine, ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel, ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20% CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be cured, usually with subsequent consolidation surgery. At that stage the disease is usually chemorefractory and there are no other chemotherapy regimens of proven benefit (7). The purpose of this study is to determine if multiple-relapsed chemorefractory pts may benefit from sorafenib monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 24, 2008
October 1, 2008
3.2 years
October 14, 2008
October 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
one year
Secondary Outcomes (1)
ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life
one year
Study Arms (1)
sorafenib
EXPERIMENTALdrug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chemotherapy Unit, Dept of Urology, Instituite of Oncology
Warsaw, 02781, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 24, 2008
Record last verified: 2008-10