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Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026130
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Fluorouracil Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026130

  Show 77 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Harvey J. Mamon, MD, PhD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Mamon HJ, Niedzwiecki D, Hollis DR, et al.: Preliminary analysis of Cancer and Leukemia Group B (CALGB) 80003: a phase II trial of gemcitabine, 5-fluorouracil (5FU), and radiation therapy (RT) in locally advanced non-metastatic pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-22, S13, 2005.

Study ID Numbers: CDR0000068988, CALGB-80003
Study First Received: November 9, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00026130  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Fluorouracil
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Adenocarcinoma
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009