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Trial record 47 of 2864 for:    Pancreatic Cancer AND pancreas

A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00424827
Recruitment Status : Completed
First Posted : January 22, 2007
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Drug: Gemcitabine/Fluorouracil with External Beam Radiation
Enrollment 11
Recruitment Details Between 2006 and 2011, twenty-six patients were screened and eleven of them were enrolled in the study. Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. Ten patients were able to tolerate and complete cycle 1 of chemoradiotherapy.
Pre-assignment Details Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. A minority of patients present with localized disease. Surgical resection only hope for long-term survival. Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases.
Arm/Group Title Single Arm
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This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.

Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.

Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title This Was a Prospective, Single Arm, Open Label Pilot Phase II
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"A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma"

This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.

Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point.

Overall Number of Baseline Participants 11
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Subjects with non-metastatic, locally advanced pancreatic adenocarcinoma. Following neoadjuvant treatment, subjects were re-evaluated for response and surgical candidacy with restaging scans.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
66
(48 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame 1-year
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Hide Analysis Population Description
Must have histologic confirmation of pancreatic adenocarcinoma with measurable disease per RECIST criteria, with locoregional disease not amenable to surgery were enrolled: based on(1) size of the tumor, 5cm; (2) lymph nodes; (3) vascular involvement or impingement on major vessels; and (4) invasion into the adjacent structures.
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation:
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Progression-free survival
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
7.17
(2.53 to 18.43)
2.Secondary Outcome
Title Biomarker Response to Chemoradiation Therapy
Hide Description 20% decrease in biomarker (CA19-9) from baseline
Time Frame 1-year
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker response (CA19-9) as defined by at least a 20% decrease from baseline
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation:
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[Not Specified]
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
7
3.Secondary Outcome
Title Resection Rate
Hide Description [Not Specified]
Time Frame 1-Year
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Hide Analysis Population Description
4 subjects underwent resection after treatment
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation:
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[Not Specified]
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
4
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Up to 2 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation:
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[Not Specified]
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
17
(7.1 to 27.6)
5.Secondary Outcome
Title Toxicity Associated With This Regimen.
Hide Description [Not Specified]
Time Frame 1-Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation:
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
2
Time Frame 3 years
Adverse Event Reporting Description Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
 
Arm/Group Title Gemcitabine/Fluorouracil With External Beam Radiation
Hide Arm/Group Description antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
All-Cause Mortality
Gemcitabine/Fluorouracil With External Beam Radiation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine/Fluorouracil With External Beam Radiation
Affected / at Risk (%) # Events
Total   4/11 (36.36%)    
Cardiac disorders   
Cardiac Dysrhythmia  1  1/11 (9.09%)  1
Gastrointestinal disorders   
nausea  1 [1]  1/11 (9.09%)  1
radiation-related duodenitis, biliary obstruction  1  1/11 (9.09%)  1
Dehydration, biliary obstruction  1  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Subject was hospitalized with severe nausea
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine/Fluorouracil With External Beam Radiation
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Lymphopenia  1  10/11 (90.91%)  17
Hypoalbuminemia  2  8/11 (72.73%)  10
hypocalcemia  2  8/11 (72.73%)  10
Gastrointestinal disorders   
Diarrhea  2  8/11 (72.73%)  17
nausea  2  7/11 (63.64%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, RECIST criteria
2
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bilal Piperdi, MD
Organization: Universiy of MA Medical School
Phone: 508-426-0442
EMail: UMMScommunications@umassmed.edu
Layout table for additonal information
Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00424827     History of Changes
Other Study ID Numbers: UM200602
First Submitted: January 18, 2007
First Posted: January 22, 2007
Results First Submitted: March 14, 2016
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017