Trial Information

A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

OBJECTIVES:

- Compare the overall survival rate of patients with metastatic pancreatic cancer treated
with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.

- Compare the time to disease progression in patients treated with these regimens.

- Compare the CA 19-9 biomarker response in patients treated with these regimens.

- Correlate the CA 19-9 biomarker response with survival in patients treated with these
regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the response in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four
treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by
cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at
least 2 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15.
Treatment repeats every 28 days for at least 2 courses in the absence of disease
progression or unacceptable toxicity.

- Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over
60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.

- Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over
90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study
within 30 months.