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Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2007

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068575
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: recombinant interferon alfa
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Cisplatin    Fluorouracil    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Trial Of Postoperative Cisplatin, Interferon, 5-FU With XRT For Patients With Resected Pancreatic Adenocarcinoma

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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-specific survival [ Designated as safety issue: No ]
  • Biochemical failure-free survival [ Designated as safety issue: No ]
  • Symptom and treatment-free survival [ Designated as safety issue: No ]
  • Qualitiy of life [ Designated as safety issue: No ]

Estimated Enrollment:   44
Study Start Date:   May 2003

Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy.
  • Determine the toxic effects of this regimen in these patients.

Secondary

  • Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE:

  • Chemoradiotherapy: Patients receive fluorouracil IV continuously and interferon alfa subcutaneously 3 times per week (total of 17 doses) on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28 fractions).
  • Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

  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 of the pancreatic head or uncinate process

    • Stage I, II, or III
  • Completely resected disease (R0 or R1)

    • Postoperative CA 19-9 less than 100
    • Study treatment must begin within 12 weeks of surgery
  • Postoperative CT scan without evidence of radiographically definable residual primary/metastatic disease or clinically significant postsurgical changes

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 9.0 g/dL

Hepatic

  • Not specified

Renal

  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • Bilateral renal function by excretory urogram (IVP) or abdominal CT scan OR at least 2/3 of 1 functioning kidney must be able to be shielded from the radiotherapy beam

Cardiovascular

  • No significant cardiovascular disease
  • No unstable angina
  • No congestive heart failure

Pulmonary

  • No severe pulmonary disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Prior history of non-pancreatic malignancy allowed at the discretion of the study chair provided patient is free of the primary cancer
  • No concurrent acute infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068575

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas     Recruiting
      Houston, Texas, United States, 77030-4009
      Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Peter W.T. Pisters, MD     M.D. Anderson Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000327752, MDA-ID-02040
First Received:   September 10, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00068575
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Digestive System Neoplasms
Pancreatic Neoplasms
Interferons
Endocrine System Diseases
Pancrelipase
Digestive System Diseases
Cisplatin
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Interferon Alfa-2a
Interferon Alfa-2b
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on October 07, 2008




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