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Phase III Randomized Study of Gemcitabine With or Without Pemetrexed Disodium in Patients With Stage II, III, or IV Unresectable Pancreatic Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Gemcitabine With or Without Pemetrexed Disodium in Treating
Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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NCI, Pharmaceutical / Industry
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CWRU-010224M NCI-G02-2125, LILLY-H3E-MC-JMES, LILLY-LILY-1201, NCT00049426
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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.
Entry Criteria Disease Characteristics:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Stage II, III, or IV disease that is not amenable to resection with curative
intent
- At least 1 bidimensionally measurable lesion with clearly defined margins by
CT scan or MRI or by palpation with both diameters at least 2 cm
- No documented brain metastases
Prior/Concurrent Therapy:
Biologic therapy - No prior immunotherapy
- No prior biological therapy for pancreatic cancer
- No concurrent immunotherapy
- No concurrent routine colony-stimulating factors
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No concurrent stimulators of thrombopoiesis
Chemotherapy - No prior chemotherapy for pancreatic cancer
- No prior fluorouracil for pancreatic cancer (including as a radiosensitizer)
- No other concurrent chemotherapy
Endocrine therapy - No prior hormonal therapy for pancreatic cancer
- No concurrent hormonal therapy for cancer
Radiotherapy - No prior radiation to whole pelvis
- Prior radiotherapy to less than 25% of bone marrow allowed
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy for small, painful metastases allowed
Surgery - No concurrent surgery for cancer
Other - At least 30 days since prior investigational agents or devices
- No other concurrent experimental medications (except thymidine)
- No other concurrent antitumor therapy
- No concurrent aspirin, salicylates, or other nonsteroidal anti-inflammatory
drugs for 2-5 days before, during, and for 2 days after each dose of
pemetrexed disodium
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL
Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver
metastases present)
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Endoscopic or radiologic stenting allowed for biliary obstructions (bilirubin
must meet study requirements and AST/ALT and alkaline phosphatase must be
no greater than 5 times ULN)
Renal - Creatinine clearance at least 45 mL/min
Cardiovascular - No unstable angina pectoris
Pulmonary - See Disease Characteristics
Other - No other malignancy within the past 5 years except carcinoma in situ of the
cervix or adequately treated nonmelanoma skin cancer
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No active infection
- No other serious concurrent systemic disorders that would preclude study
- No uncontrolled diabetes mellitus
- No weight loss of 10% or more within the past 6 weeks
- No inability or unwillingness to take folic acid or vitamin B12
supplementation
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months
after study
Expected Enrollment A total of 520 patients (260 per treatment arm) will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Ireland Cancer Center at University Hospitals/Case Medical Center | | | Joanna Brell, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas | | Trial Start Date | | 2002-07-17 | | Registered in ClinicalTrials.gov | | NCT00049426 | | Date Submitted to PDQ | | 2002-09-16 | | Information Last Verified | | 2003-03-21 | | NCI Grant/Contract Number | | P30-CA43703 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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