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Sponsored by: |
Fondation Wygrajmy Zdrowie |
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Information provided by: | Fondation Wygrajmy Zdrowie |
ClinicalTrials.gov Identifier: | NCT00772694 |
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 | Intervention | Phase |
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Testicular Cancer |
Drug: sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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sorafenib: Experimental
drug
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Drug: sorafenib
tablets 200mg, 400mg bid continuously in 4-week cycles
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Failure on prior regimens will be defined as either:
Exclusion Criteria:
Contact: Iwona A Skoneczna, MD | +48225462098 | i.skoneczna@coi.waw.pl |
Contact: Agnieszka Chaladaj-Kujawska, MD | +48225462057 |
Poland | |
Chemotherapy Unit, Dept of Urology, Instituite of Oncology | Recruiting |
Warsaw, Poland, 02781 | |
Principal Investigator: Iwona A Skoneczna, MD | |
Sub-Investigator: Agnieszka Chaladaj-Kujawska, MD |
Responsible Party: | Fondation Wygrajmy Zdrowie ( dr Iwona Skoneczna ) |
Study ID Numbers: | 12602, PL/ 183/UR/CEBK/04/08, EudraCT 2007-007599-40 |
Study First Received: | October 14, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00772694 |
Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
testicular cancer germ cell cancer sorafenib |
Genital Neoplasms, Male Gonadal Disorders Testicular Diseases Endocrine System Diseases Urogenital Neoplasms Testicular Neoplasms Genital Diseases, Male |
Malignant germ cell tumor Recurrence Carcinoma Testicular cancer Endocrinopathy Sorafenib Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |