Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Harvey J. Mamon

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026130
Information obtained from ClinicalTrials.gov on December 14, 2011

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