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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049426 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: cyanocobalamin Drug: folic acid Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-1714 |
Study Chair: | Joanna M. Brell, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000258097, CWRU-010224M, NCI-G02-2125, LILLY-H3E-MC-JMES, LILLY-LILY-1201 |
Study First Received: | November 12, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00049426 |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Hydroxocobalamin Endocrine System Diseases Vitamin B 12 Pancrelipase Pemetrexed Folic Acid |
Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Adenocarcinoma Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Vitamin B Complex Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics Growth Substances Physiological Effects of Drugs Hematologic Agents |
Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Vitamins Therapeutic Uses Micronutrients |