A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas
- Compare the overall survival of patients with stage II, III, or IV unresectable
pancreatic cancer treated with gemcitabine with or without pemetrexed disodium.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the time to treatment failure and duration of response in patients treated with
- Compare tumor response rate in patients treated with these regimens.
- Compare the effects of these regimens on health-related quality of life in these
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are
stratified according to baseline ECOG performance status (0-1 vs 2), disease stage (II or
III vs IV), baseline homocysteine level (at least 12 µmol/L vs less than 12 µmol/L), and
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and
pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 3 weeks for up
to 8 courses in the absence of disease progression or unacceptable toxicity. Patients
also receive oral folic acid and cyanocobalamin intramuscularly every 9 weeks beginning
1-2 weeks before day 1 and continuing until 3 weeks after end of study therapy.
- Arm II: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, and 15.
Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of each course, and then every 3 months
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Joanna M. Brell, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|