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Trial record 68 of 266 for:    Pancreatic Cancer AND Resectable

Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT00557492
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : December 12, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Amer Zureikat, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Avastin (bevacizumab)
Drug: Gemzar (Gemcitabine)
Radiation: external beam radiotherapy
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Period Title: Overall Study
Started 59
Completed 58 [1]
Not Completed 1
Reason Not Completed
Change in health insurance             1
[1]
Evaluable for outcomes
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
60
(37 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
29
  49.2%
Male
30
  50.8%
1.Primary Outcome
Title Rate of Margin Negative Surgical Resection (R0 Resection Rate)
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent laparoscopy and pancreatic resection.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(75 to 96)
2.Primary Outcome
Title Rate of Pathologic Complete Response (pCR)
Hide Description Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent laparoscopy and pancreatic resections.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.3
(0.1 to 12)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes entire study cohort.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
16.8
(14.9 to 21.3)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes participants who underwent laparoscopy and pancreatic resection.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
19.7
(16.5 to 28.2)
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes entire study cohort.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: months
6.6
(4.9 to 12.4)
6.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes participants who underwent laparoscopy and pancreatic resection.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 43
Median (95% Confidence Interval)
Unit of Measure: months
12.9
(7.0 to 18.7)
7.Secondary Outcome
Title Rate of Surgical Resection
Hide Description Number of participants that underwent resection / per the total number of evaluable participants
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
74
8.Secondary Outcome
Title Radiographic Tumor Response
Hide Description CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: Participants
metastatic progression (at restaging) 4
stable disease 39
partial response 5
progressive disease 10
9.Secondary Outcome
Title Ca 19-9 Level (in Serum) - Biomarker Response
Hide Description Percentage decrease in Ca 19-9 level (in serum)
Time Frame Baseline and up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that did NOT demonstrate metastatic progression upon restaging CT.
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description:
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: percentage decrease in serum Ca19-9 leve
25  (80)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FDR GEM + BEV +/- BEV/RT
Hide Arm/Group Description Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
All-Cause Mortality
FDR GEM + BEV +/- BEV/RT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FDR GEM + BEV +/- BEV/RT
Affected / at Risk (%)
Total   10/59 (16.95%) 
Blood and lymphatic system disorders   
Hemorrhage/Bleeding  1/59 (1.69%) 
Gastrointestinal disorders   
Dehydration  1/59 (1.69%) 
Leak (including anastomotic), GI, Pancreas  1/59 (1.69%) 
Nausea  1/59 (1.69%) 
Obstruction, GI, Small bowel NOS  1/59 (1.69%) 
General disorders   
Pain, Abdomen NOS  1/59 (1.69%) 
Hepatobiliary disorders   
Hepatobiliary/Pancreas  1/59 (1.69%) 
Infections and infestations   
Infection  1/59 (1.69%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS  2/59 (3.39%) 
Skin and subcutaneous tissue disorders   
Wound complication, non-infectious  1/59 (1.69%) 
Vascular disorders   
Thrombosis/thrombus/embolism  3/59 (5.08%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FDR GEM + BEV +/- BEV/RT
Affected / at Risk (%)
Total   50/59 (84.75%) 
Blood and lymphatic system disorders   
Leukocytes (total WBC)  5/59 (8.47%) 
Platelets  7/59 (11.86%) 
Neutrophils/granulocytes (ANC/AGC)  8/59 (13.56%) 
Hemoglobin  9/59 (15.25%) 
Gastrointestinal disorders   
Gastrointestinal  6/59 (10.17%) 
Anorexia  7/59 (11.86%) 
Constipation  7/59 (11.86%) 
Diarrhea  10/59 (16.95%) 
Vomiting  10/59 (16.95%) 
Nausea  21/59 (35.59%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  21/59 (35.59%) 
Pain  5/59 (8.47%) 
Pain, Head/headache  6/59 (10.17%) 
Pain, Abdomen NOS  12/59 (20.34%) 
Metabolism and nutrition disorders   
Calcium, serum-low (hypocalcemia)  5/59 (8.47%) 
Bilirubin (hyperbilirubinemia)  7/59 (11.86%) 
Potassium, serum-low (hypokalemia)  8/59 (13.56%) 
Albumin, serum-low (hypoalbuminemia)  9/59 (15.25%) 
Sodium, serum-low (hyponatremia)  9/59 (15.25%) 
Alkaline phosphatase  11/59 (18.64%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  13/59 (22.03%) 
ALT, SGPT (serum glutamic pyruvic transaminase)  16/59 (27.12%) 
Glucose, serum-high (hyperglycemia)  22/59 (37.29%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue  4/59 (6.78%) 
Nervous system disorders   
Mood alteration, Anxiety  6/59 (10.17%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary/Upper Respiratory  4/59 (6.78%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin  4/59 (6.78%) 
Hair loss/alopecia (scalp or body)  6/59 (10.17%) 
Pruritus/itching  6/59 (10.17%) 
Rash/desquamation  6/59 (10.17%) 
Wound complication, non-infectious  6/59 (10.17%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Herbert Zeh, MD
Organization: UPMC CancerCenter
Phone: 4126922852
EMail: zehxhx@upmc.edu
Layout table for additonal information
Responsible Party: Amer Zureikat, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00557492     History of Changes
Obsolete Identifiers: NCT00428324
Other Study ID Numbers: 06-035
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: August 10, 2016
Results First Posted: December 12, 2016
Last Update Posted: September 25, 2018