NCT00789763

Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic Carcinoma

Open-label, Multicentric Phase I-II Trial to Evaluate the Efficacy and Safety of the Combination of Sorafenib (BAY 43-9006), Gemcitabine and Concurrent Radiotherapy, in Locally Advanced Pancreatic Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response rate, Overall survival, Toxicity profile

Detailed description

Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy Definition of maximum tolerated dose (MTD): The MTD is defined as the highest dose level which can be given to 6 patients such that no more than 1 patient experiences a DLT . Definition of Recommended Dose (DR): Is the MTD Definition of Dose-limiting toxicity (DLT): DLT will be defined as any of the following occurring during the period of treatment and regarded as related to the combination regimen. * Grade 4 thrombocytopenia persisting greater than 4 days, or with bleeding requiring platelet transfusion * Grade 4 neutropenia lasting more than 7 days * Febrile neutropenia (≥ 38.5oC) with an absolute neutrophil count ≤ 1000/mm3 * Any grade 3 or 4 non-hematologic toxicity related to the combination \[occurring despite optimal supportive care, if applicable\] except hyperglycemia, hypoglycemia, deep venous thrombosis, or hyperbilirubinemia secondary to stent malfunction. * Hypertension that is symptomatic and not managed by maximal use of three different classes of antihypertensives, or any episode of malignancy hypertension (Detailed Dose Modifications and G-CSF use in case of febrile neutropenia will be outlined in the full protocol version) Phase II Primary objective: Activity profile evaluating Progression-free rates (PFR) at 6 months Secondary objective: Response rate Overall survival Toxicity profile

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	300 mg/m2/one per week, i.v., during 5 weeks.
RADIATION	Radiotherapy	1.8 Gy/day 5 days per week during 5 weeks (total dose 45Gy)
DRUG	Sorafenib	200-800 mg/day p.o. during 5 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-01-01
• Completion: 2012-01-01
• First posted: 2008-11-13
• Last updated: 2012-11-29

Locations

4 sites across 1 country: Spain