A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib (Tarceva), Gemcitabine, Bevacizumab (Avastin), and Capecitabine in Advanced Pancreatic Cancer
To establish the safety and efficacy of a combination of four drugs (capecitabine,
gemcitabine, erlotinib and bevacizumab) in the treatment of patients with locally advanced
or metastatic pancreatic cancer. The study will be divided into two parts:
Part A (Phase I ): Is to establish the optimal dose of capecitabine for combination with
gemcitabine, bevacizumab and erlotinib. This part of the study is necessary in order to
characterise any increased side effects that may occur as a result of this combination of
drugs. The dose of capecitabine will be increased in cohorts containing 3 to 6
patients(according to standard dose escalation study design) whilst side effects are closely
monitored. The doses of the other three drugs will remain fixed during this period:
- Gemcitabine: 1000 mg/m2 Days 1, 8, 15
- Bevacizumab: 5 mg/kg every two weeks iv
- Erlotinib: 100 mg/day orally
Maximum tolerated dose is the dose at which 2 out of a cohort of three to six patients
experience dose-limiting toxicity within the first cycle (28 days) of treatment. The
recommended dose for further evaluation will be one dose level below this.
Part B (Phase II): Once a recommended dose of capecitabine has been chosen, this will be
used for the remainder of the trial to further characterise the efficacy and safety of the
drug combination in this group of patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Part A (Phase I): Dose-limiting Toxicity (DLT)
David Cunningham, MD, FRCP
Principal Investigator
The Royal Marsden Hospital NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CCR2631
NCT00260364
November 2005
December 2009
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