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Trial record 95 of 266 for:    Pancreatic Cancer AND Resectable

Perioperative Therapy for Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00609336
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew Coveler, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions Drug: gemcitabine hydrochloride
Drug: docetaxel
Drug: capecitabine
Radiation: intensity-modulated radiation therapy
Drug: oxaliplatin
Procedure: pancreatic surgical procedure
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

gemcitabine: Given IV

oxaliplatin: Given IV

Period Title: Overall Study
Started 35
Surgery 22
Completed 22
Not Completed 13
Reason Not Completed
Protocol Violation             3
Death             1
LA or Met at Surgery             9
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 32
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All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
62
(46 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
15
  46.9%
Male
17
  53.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
30
  93.8%
Unknown or Not Reported
2
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
1
   3.1%
Asian
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
30
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Hide Description Time at which Kaplan-Meier estimate of overall survival drops below 50%
Time Frame 5 years
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All eligible patients
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
31.6
(14.2 to 58.1)
2.Secondary Outcome
Title Percent of Patients Surviving at 5 Years
Hide Description Kaplan-Meier estimate of overall survival at 5 years
Time Frame Up to 5 years
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all eligible patients
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of eligible pts alive
31.6
3.Secondary Outcome
Title Median Recurrence Free Survival Following Pancreaticoduodenectomy
Hide Description The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
Time Frame From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years
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Among eligible patients who received surgery
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
31.3 [1] 
(12.5 to NA)
[1]
Upper limit is infinite.
4.Secondary Outcome
Title Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Hide Description Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time Frame Up to 7 years
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Clinical response not collected.
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
Hide Description The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90
Time Frame Up to 7 years
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all eligible patients with non-missing data
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
20
  90.9%
6.Secondary Outcome
Title CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Hide Description Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
Time Frame Up to 26 weeks after surgery
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Biomarker data not collected.
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Surgical Completion Rate and Complication Rate
Hide Description [Not Specified]
Time Frame Up to 6 weeks following the completion of chemoradiotherapy
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all eligible patients
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
Completion rate Number Analyzed 32 participants
22
  68.8%
Complication rate Number Analyzed 22 participants
2
   9.1%
8.Secondary Outcome
Title Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hide Description [Not Specified]
Time Frame Up to 26 weeks after surgery (the end of adjuvant chemotherapy)
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All eligible patients
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: occurrence of toxicities
Any Grade 2 CTCAE toxicity 21
Any Grade 3 CTCAE toxicity 121
Any Grade 4 CTCAE toxicity 14
9.Secondary Outcome
Title Percent of Patients Surviving at Annual Intervals
Hide Description [Not Specified]
Time Frame 5 years
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[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

gemcitabine: Given IV

oxaliplatin: Given IV

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
Year 1 81
Year 2 62
Year 3 45
Year 4 37
Year 5 31
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
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gemcitabine hydrochloride: Given IV

docetaxel: Given IV

capecitabine: Given PO

intensity-modulated radiation therapy: Undergo IMRT

oxaliplatin: Given IV

pancreatic surgical procedure: Undergo pancreaticoduodenectomy

therapeutic conventional surgery: Undergo therapeutic conventional surgery

gemcitabine: Given IV

oxaliplatin: Given IV

All-Cause Mortality
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Affected / at Risk (%)
Total   --/--    
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Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Affected / at Risk (%) # Events
Total   32/35 (91.43%)    
Blood and lymphatic system disorders   
Anemia  6/35 (17.14%)  9
Fever, Neutropenic  3/35 (8.57%)  3
Neutropenia  24/35 (68.57%)  31
Thrombocytopenia  10/35 (28.57%)  12
Thrombotic Microangiopathy  1/35 (2.86%)  1
Cardiac disorders   
Atrial Fibrillation  1/35 (2.86%)  1
Myocardial Infarction  1/35 (2.86%)  2
Transient Ischemic Attacks  1/35 (2.86%)  1
Gastrointestinal disorders   
Diarrhea  5/35 (14.29%)  5
Nausea  3/35 (8.57%)  3
Vomiting  2/35 (5.71%)  2
Entero Cutaneous Fistula  1/35 (2.86%)  1
Lower GI Bleed  1/35 (2.86%)  1
Odynophagia  1/35 (2.86%)  1
General disorders   
Fatigue  4/35 (11.43%)  4
Shoulder Pain  1/35 (2.86%)  1
Hepatobiliary disorders   
Cholangitis  1/35 (2.86%)  1
Cholangitis With Stent Occlusion  1/35 (2.86%)  1
Cholecystic Abcess  1/35 (2.86%)  1
Intrahepatic Absesses  1/35 (2.86%)  1
Non-Malignant Ascitess  1/35 (2.86%)  1
Obstructive Jaundice  1/35 (2.86%)  1
Portal Vein Thrombosis  1/35 (2.86%)  1
Transaminitis  1/35 (2.86%)  1
Infections and infestations   
Infection  1/35 (2.86%)  2
Bacterial Sepsis  1/35 (2.86%)  1
Urinary tract infection  2/35 (5.71%)  2
Investigations   
Elevated Bilirubin  4/35 (11.43%)  4
Metabolism and nutrition disorders   
Anorexia  1/35 (2.86%)  1
Dehydration  1/35 (2.86%)  1
Hypoalbuminemia  1/35 (2.86%)  1
Hypoatremic  1/35 (2.86%)  1
Hyponatremia  1/35 (2.86%)  1
Nervous system disorders   
Syncope  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Mucositis  3/35 (8.57%)  3
Pneumonitis  1/35 (2.86%)  1
Nose Bleeds  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
Hand-foot Syndrome  20/35 (57.14%)  22
Anasarca  1/35 (2.86%)  1
Pruritus  1/35 (2.86%)  1
Vascular disorders   
Hypertension  2/35 (5.71%)  3
Hypotension  2/35 (5.71%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Affected / at Risk (%) # Events
Total   14/32 (43.75%)    
Blood and lymphatic system disorders   
Neutropenia  3/32 (9.38%)  3
Thrombocytopenia  2/32 (6.25%)  2
Gastrointestinal disorders   
Vomiting  1/32 (3.13%)  1
Hepatobiliary disorders   
Cholangitis  1/32 (3.13%)  1
Transaminase  1/32 (3.13%)  1
Infections and infestations   
Infection  1/32 (3.13%)  1
Investigations   
Elevated Bilirubin  1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders   
Maculopapular Rash  1/32 (3.13%)  1
Skin and subcutaneous tissue disorders   
Hand Foot Syndrome  7/32 (21.88%)  8
Maculopapular Rash  1/32 (3.13%)  1
Rash - Upper Torso  1/32 (3.13%)  1
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: Andrew Coveler, MD
Organization: University of Washington
Phone: 206-288-7509
EMail: acoveler@uw.edu
Layout table for additonal information
Responsible Party: Andrew Coveler, University of Washington
ClinicalTrials.gov Identifier: NCT00609336     History of Changes
Other Study ID Numbers: 6511
NCI-2010-00553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6511 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2008
First Posted: February 7, 2008
Results First Submitted: March 21, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017