Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


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.


Study summary:

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 intravenous (IV) continuously and interferon alfa subcutaneously (SQ) 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.


Criteria:

Inclusion Criteria: 1. 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. 2. Postoperative (pre-treatment) computed tomography (CT) scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes. 3. Staging studies completed within three weeks +/- 3 days of protocol registration. 4. 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. 5. Postoperative serum calcium (CA) 19-9 < 100. 6. Performance status: Zubrod 0 or 1. 7. 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 8. 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. 9. No acute infections at the time of therapy initiation. 10. Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent. 11. Patients must sign a study-specific consent form, which is attached to this protocol. 12. 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. Exclusion Criteria: 1. Residual (clinical or CT definable) metastatic or incompletely resected local disease. 2. Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal cytology. 3. Patients with a history of hypersensitivity to interferon alfa-2b. 4. Patients with significant cardiovascular disease, such as unstable angina or congestive heart failure. 5. Pregnancy or breastfeeding. 6. Patients with severe pulmonary disease. 7. Children under the age of 18 are excluded (as the disease is rare and toxicity profile of this regimen untested in pediatric patients). 8. Presence or history of severe depression.


Study is Available At:


Original ID:

ID02-040


NCT ID:

NCT00068575


Secondary ID:

P30CA016672


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

29


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter W. Pisters, MD
Study Chair
M.D. Anderson Cancer Center

Study Dates

Start Date:May 2002
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 13, 2012
First Received Date:September 10, 2003
First Results Date:January 23, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Median Overall Survival (OS)
Time Frame:Participants followed till disease progression or death (approximately 6 years)
Safety Issues:False
Description:Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.

Study Interventions

Intervention Type:Biological
Name:Recombinant Interferon Alfa
Description: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.
Arm Name:Postoperative Chemoradiation Regimen
Other Name:Interferon alfa-2b
Intervention Type:Drug
Name:Cisplatin
Description: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.
Arm Name:Postoperative Chemoradiation Regimen
Other Name:Platinol-AQ
Intervention Type:Drug
Name:Fluorouracil
Description: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.
Arm Name:Postoperative Chemoradiation Regimen
Other Name:5-fluorouracil
Intervention Type:Radiation
Name:Radiation Therapy
Description:External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.
Arm Name:Postoperative Chemoradiation Regimen
Other Name:RT

Study Arms

Study Arm Type:Experimental
Arm Name:Postoperative Chemoradiation Regimen
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.