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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	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	Biological: recombinant interferon alfa Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Radiation: radiation therapy	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Surgery

Drug Information available for: Fluorouracil Cisplatin Interferon alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000327752, MDA-ID-02040
Study First Received:	September 10, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00068575 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms

Interferon-alpha
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Interferons
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil

ClinicalTrials.gov processed this record on November 27, 2009