Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. It is not yet known whether gemcitabine is more effective with or without pemetrexed disodium in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine combined with pemetrexed disodium to that of gemcitabine alone in treating patients who have unresectable stage II, stage III, or stage IV pancreatic cancer.
Dietary Supplement: cyanocobalamin
Dietary Supplement: folic acid
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas|
|Study Start Date:||July 2002|
- 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 these regimens.
- Compare tumor response rate in patients treated with these regimens.
- Compare the effects of these regimens on health-related quality of life in these patients.
- 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 thereafter.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this study.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-1714|
|Study Chair:||Joanna M. Brell, MD||Case Comprehensive Cancer Center|