Trial Information

Phase I/II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Combined Chemo-radiation and/or Surgical Resection for Locally Advanced Pancreatic Cancer

OBJECTIVES:

- Determine the response rate of patients with locally advanced pancreatic cancer after
induction therapy with gemcitabine and cisplatin.

- Determine the maximum tolerated dose of gemcitabine and cisplatin chemotherapy combined
with radiation therapy in these patients.

- Determine the overall response rates in these patients after this combined modality
regimen following induction chemotherapy.

- Determine the resectability rate for locally advanced pancreatic lesions treated with
this regimen.

- Determine the time to failure for the entire treatment program.

OUTLINE: This is a dose-escalation study.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Following gemcitabine,
patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Course is repeated every 4
weeks. After 2 courses of induction chemotherapy, disease is restaged.

Patients may then receive radiotherapy in addition to chemotherapy. Radiotherapy is given
daily for 5 weeks and 3 days. During radiotherapy, cohorts of 3 patients are treated with
escalating doses of gemcitabine and cisplatin administered as described above in induction
chemotherapy. The maximum tolerated dose (MTD) is defined as the lowest dose at which no
more than 2 of 6 or 2 of 3 patients experience dose limiting toxicity. When the MTD has been
determined, additional patients accrued into the study receive the dose level immediately
below the MTD.

If after 2 courses of induction chemotherapy with gemcitabine and cisplatin the tumor is
radiographically considered resectable by operating surgeon, the patient undergoes surgical
exploration or laparoscopy for staging and verification of resectability. If the tumor is
found to be resectable without evidence of distant disease, the patient undergoes complete
surgical resection and radiation plus adjuvant gemcitabine and cisplatin.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 15-36 patients will be accrued for the Phase I portion of
this study and there will be 14-25 patients accrued into the Phase II portion of this study.