A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase III Trial Of ALIMTA Plus GEMZAR In Patients With Unresectable Or Metastatic Cancer Of The Pancreas
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.
Inclusion 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 clinically significant third-space fluid collection (e.g., ascites or pleural
effusions) NOTE: Fluid collections may be drained
- No documented brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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)
- 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
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy
- No prior biological therapy for pancreatic cancer
- No concurrent immunotherapy
- No concurrent routine colony-stimulating factors
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Joanna M. Brell, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000258097
NCT ID:
NCT00049426
Start Date:
July 2002
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
