Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy (GCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00772694|
Recruitment Status : Unknown
Verified October 2008 by Fondation Wygrajmy Zdrowie.
Recruitment status was: Recruiting
First Posted : October 15, 2008
Last Update Posted : October 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Testicular Cancer||Drug: sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
tablets 200mg, 400mg bid continuously in 4-week cycles
Other Name: Nexavar
- Progression free survival [ Time Frame: one year ]
- ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772694
|Contact: Iwona A Skoneczna, MDemail@example.com|
|Contact: Agnieszka Chaladaj-Kujawska, MD||+48225462057|
|Chemotherapy Unit, Dept of Urology, Instituite of Oncology||Recruiting|
|Warsaw, Poland, 02781|
|Principal Investigator: Iwona A Skoneczna, MD|
|Sub-Investigator: Agnieszka Chaladaj-Kujawska, MD|