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Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00026130
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
Study Start Date : September 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
Drug: fluorouracil
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
Other Name: 5FU

Drug: gemcitabine 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

Radiation: radiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 9 months up to 3 years post treatment ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs ]
  2. Clinical Response [ Time Frame: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs ]
  3. CA19-9 Levels [ Time Frame: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs ]
    Biomarker response

  4. Toxicity [ Time Frame: q cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026130


  Show 77 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Harvey J. Mamon, MD, PhD Dana-Farber/Brigham and Women's Cancer Center

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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00026130     History of Changes
Other Study ID Numbers: CALGB-80003
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-80003
CDR0000068988 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs