Chemoradiation in Locally Advanced Pancreatic Cancer

NCT00262951 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2004LS0600410M64346
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

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)

• Number of Patients in Whom Tumor Was Resectable

  Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.

  Up to 5 Years or Until Disease Progression

Secondary Outcomes (1)

• Overall Survival

  Up to 5 Years or Date of Death, Whichever Occurred First

Study Arms (1)

Pancreatic Adenocarcinoma Patients

EXPERIMENTAL

Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery).

Biological: recombinant interferon alfa; Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy; Procedure: Resection of tumor

Interventions

recombinant interferon alfa BIOLOGICAL

administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1

Also known as: IFN alpha, IFN-alpha-2b

Pancreatic Adenocarcinoma Patients

cisplatin DRUG

administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1

Also known as: cisplatinum, cis-diamminedichloroplatinum(II) (CDDP)

Pancreatic Adenocarcinoma Patients

fluorouracil DRUG

administered at a dose of 175 mg/m\^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m\^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3

Also known as: 5-FU

Pancreatic Adenocarcinoma Patients

radiation therapy RADIATION

5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).

Pancreatic Adenocarcinoma Patients

Resection of tumor PROCEDURE

After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.

Pancreatic Adenocarcinoma Patients

Eligibility Criteria

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

You may qualify if:

• Patient must have newly diagnosed computated tomography (CT) and endoscopic ultrasound(EUS) stage Tx-4, N0-1, M0 adenocarcinoma of pancreas according to the American Joint Committee on Cancer (AJCC) staging system. The following cell types will NOT be eligible: adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma
• Treatment must begin within 60 days of diagnosis
• Must have locally advanced inoperable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan of the chest, endoscopic ultrasound and CT scan with intravenous (IV) contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration.
• No prior systemic chemotherapy or radiation therapy for pancreatic cancer
• Documented Eastern Cooperative Oncology Group (ECOG/Zubrod) performance status 0-1 within 14 days prior to registration
• Adequate hematologic, renal and hepatic function as defined by the following laboratory values (completed within 14 days prior to registration)
• white blood cell (WBC) \> 3,000 mm3
• absolute neutrophil count (ANC) \> 1,500 mm3
• platelet count ≥ 100,000 mm3
• hemoglobin \> 9.5 g/dl
• serum creatinine \< 1.5 times institutional upper limit of normal (ULN)
• total bilirubin ≤ 3 mg/dl
• AST (SGOT) \< 4.0 times institutional ULN
• ALT (SGPT) \< 4.0 times institutional ULN
• alkaline phosphatase \< 2.0 times institutional ULN

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Interferon-alpha; Introns; Cisplatin; Fluorouracil; Radiotherapy; Transurethral Resection of Bladder

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; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Edward Greeno, M.D.
• Organization: University of Minnesota, Masonic Cancer Center

green049@umn.edu

612-626-6418

Study Officials

• Edward W. Greeno, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 6, 2005
• First Posted: December 7, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 28, 2017
• Results First Posted: February 3, 2012

Record last verified: 2017-12

Locations

US (1)