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

NCT00068575 | Completed Phase 2 Results

• 4 other identifiers: ID02-040P30CA016672MDA-ID-02040CDR0000327752
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival (OS)

  Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.

  Participants followed till disease progression or death (approximately 6 years)

Study Arms (1)

Postoperative Chemoradiation Regimen

EXPERIMENTAL

Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.

Biological: Recombinant Interferon Alfa; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiation Therapy

Interventions

Recombinant Interferon Alfa BIOLOGICAL

3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.

Also known as: Interferon alfa-2b, IFN

Postoperative Chemoradiation Regimen

Cisplatin DRUG

30 mg/m\^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.

Also known as: Platinol-AQ, Platinol, CDDP

Postoperative Chemoradiation Regimen

Fluorouracil DRUG

175 mg/m\^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.

Also known as: 5-fluorouracil, Adrucil, Efudex

Postoperative Chemoradiation Regimen

Radiation Therapy RADIATION

External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.

Also known as: RT, Radiatherapy

Postoperative Chemoradiation Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process \[American Joint Committee on Cancer (AJCC) Stage I-III\]. Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must begin within 12 weeks of surgery.
• Postoperative (pre-treatment) computed tomography (CT) scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes.
• Staging studies completed within three weeks +/- 3 days of protocol registration.
• Hemoglobin (Hb) \>9.0 g/%, White Blood Count (WBC) \>3,000 cells/mm3 (Absolute neutrophil count (ANC)\>1,500 cells/mm3), platelets \>75,000 cells/mm3.
• Postoperative serum calcium (CA) 19-9 \< 100.
• Performance status: Zubrod 0 or 1.
• Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60 ml/min or greater by the following formula: Creatinine clearance rate (CrCl) = (140 - age) \* Weight (kg) \* 0.85 (female) OR \* 1.00 (male) 72 \* serum creatinine
• Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded from the radiation beam.
• No acute infections at the time of therapy initiation.
• Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
• Patients must sign a study-specific consent form, which is attached to this protocol.
• Patients with a prior history of non-pancreatic malignancy who are free of disease from their primary cancer may be eligible at the discretion of the study chair.

You may not qualify if:

• Residual (clinical or CT definable) metastatic or incompletely resected local disease.
• Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal cytology.
• Patients with a history of hypersensitivity to interferon alfa-2b.
• Patients with significant cardiovascular disease, such as unstable angina or congestive heart failure.
• Pregnancy or breastfeeding.
• Patients with severe pulmonary disease.
• Children under the age of 18 are excluded (as the disease is rare and toxicity profile of this regimen untested in pediatric patients).
• Presence or history of severe depression.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Schering-Plough: collaborator

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Interferon-alpha; Interferon alpha-2; Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Peter Pisters, MD / Professor
• Organization: UT MD Anderson Cancer Center

asanmigu@mdanderson.org

Study Officials

• Peter W. Pisters, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: May 1, 2002
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 15, 2012
• Results First Posted: February 14, 2012

Record last verified: 2012-02

Locations

US (1)