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Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer

2014-08-27 03:55:40 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

cyanocobalamin, folic acid, gemcitabine hydrochloride, pemetrexed disodium

Location

Ireland Cancer Center
Cleveland
Ohio
United States
44106-1714

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:40-0400

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Medical and Biotech [MESH] Definitions

The active metabolite of FOLIC ACID. Leucovorin is used principally as its calcium salt as an antidote to folic acid antagonists which block the conversion of folic acid to folinic acid.

Cell surface receptors that bind to and transport FOLIC ACID, 5-methyltetrahydrofolate, and a variety of folic acid derivatives. The receptors are essential for normal NEURAL TUBE development and transport folic acid via receptor-mediated endocytosis.

Derivatives of folic acid (pteroylglutamic acid). In gamma-glutamyl linkage they are found in many tissues. They are converted to folic acid by the action of pteroylpolyglutamate hydrolase or synthesized from folic acid by the action of folate polyglutamate synthetase. Synthetic pteroylpolyglutamic acids, which are in alpha-glutamyl linkage, are active in bacterial growth assays.

A nutritional condition produced by a deficiency of FOLIC ACID in the diet. Many plant and animal tissues contain folic acid, abundant in green leafy vegetables, yeast, liver, and mushrooms but destroyed by long-term cooking. Alcohol interferes with its intermediate metabolism and absorption. Folic acid deficiency may develop in long-term anticonvulsant therapy or with use of oral contraceptives. This deficiency causes anemia, macrocytic anemia, and megaloblastic anemia. It is indistinguishable from vitamin B 12 deficiency in peripheral blood and bone marrow findings, but the neurologic lesions seen in B 12 deficiency do not occur. (Merck Manual, 16th ed)

Proteins involved in the transport of FOLIC ACID and folate derivatives across the CELLULAR MEMBRANE.

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