NCT00440167

Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: PD Dr. med. Volker Heinemann · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
DRUG	Capecitabine	Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
DRUG	Erlotinib	Erlotinib 150 mg/d oral, daily without break

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2007-02-26
• Last updated: 2012-07-09