Pancreatic Cancer
Conditions
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
Detailed description
OBJECTIVES: * Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy. * Determine the time to progression in patients treated with this regimen. * Determine the overall clinical response in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks. Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.
Interventions
DRUGfluorouracil
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
DRUGgemcitabine hydrochloride
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
RADIATIONradiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic adenocarcinoma * Non-metastatic disease that is unresectable due to any of the following: * Tumor greater than 5 cm * Bulky lymph nodes greater than 2 cm, but within the radiation port * Vascular involvement or impingement of major vessels * Involvement of colon, adrenal glands, or kidney * Measurable or evaluable disease * No prior therapy for pancreatic adenocarcinoma * No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * CTC 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months Other: * No other uncontrolled serious medical or psychiatric illness that would preclude study compliance * No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics Radiotherapy: * No prior abdominal radiotherapy Surgery: * At least 2 weeks since prior major surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 9 months up to 3 years post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs | — |
| Clinical Response | q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs | — |
| CA19-9 Levels | q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs | Biomarker response |
| Toxicity | q cycle | — |
Countries
United States
Outcome results
None listed