Trial Information

A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma

OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride
when combined with radiotherapy in patients with unresectable and/or metastatic
pancreatic or biliary tract adenocarcinoma. (Part 1)

- Determine the MTD of erlotinib hydrochloride and gemcitabine hydrochloride when
combined with oxaliplatin at the MTD and radiotherapy in these patients. (Part 2)

OUTLINE: This is a multicenter, nonrandomized, parallel group, uncontrolled, open-label,
dose-escalation study of gemcitabine hydrochloride, oxaliplatin, and erlotinib
hydrochloride.

- Part 1: Patients receive gemcitabine hydrochloride IV over 30-60 minutes and
oxaliplatin IV on day 1. Patients also undergo external beam radiotherapy (EBRT) once
daily on days 1-5. Treatment repeats every 7 days for up to 6 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and
oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
(DLT). Up to 10 patients are treated at the MTD.

- Part 2: Patients receive gemcitabine hydrochloride, oxaliplatin*, and EBRT as in part
1. Patients also receive oral erlotinib hydrochloride once daily on days 1-5. Treatment
repeats every 7 days for up to 6 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and erlotinib
hydrochloride until the MTD is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience DLT. Up to 10 patients are treated at the MTD.

NOTE: *Patients receive oxaliplatin at the MTD determined in part 1.

After completion of study treatment, patients are followed every 3 months.