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Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00416793
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : July 15, 2011
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer
Interventions Drug: bortezomib
Drug: carboplatin
Other: laboratory biomarker analysis
Enrollment 9
Recruitment Details Recruitment period: December 7, 2006 to August 26, 2008. All recruitment was done at UT MD Anderson Cancer Center.
Pre-assignment Details The study was terminated early since the protocol met prospective criteria for early stopping.
Arm/Group Title Bortezomib + Carboplatin
Hide Arm/Group Description Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Bortezomib + Carboplatin
Hide Arm/Group Description Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
49
(49 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
2
  22.2%
Male
7
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Overall Survival Rate at 6 Months
Hide Description Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.
Time Frame up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol; Limited analysis due to study early termination.
Arm/Group Title Bortezomib + Carboplatin
Hide Arm/Group Description:
Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Proportion of participants
0
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.
Time Frame Evaluated at end of every second 3 week cycle for response
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from December 27, 2006 to June 6,2008 or a total of 1 year and 5 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib + Carboplatin
Hide Arm/Group Description Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
All-Cause Mortality
Bortezomib + Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib + Carboplatin
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bortezomib + Carboplatin
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Plate Count decrease  1  5/9 (55.56%) 
Cardiac disorders   
Cardiac Pain  1  2/9 (22.22%) 
Myocardial Ischemia  1  1/9 (11.11%) 
Eye disorders   
Blurred vision  1  1/9 (11.11%) 
Gastrointestinal disorders   
Abdominal Pain  1  4/9 (44.44%) 
Alopecia  1  1/9 (11.11%) 
Constipation  1  5/9 (55.56%) 
Diarrhea  1  4/9 (44.44%) 
Gastrointestinal Pain  1  1/9 (11.11%) 
Mucositis (oral)  1  1/9 (11.11%) 
Nausea  1  5/9 (55.56%) 
Vomiting  1  4/9 (44.44%) 
General disorders   
Chills  1  1/9 (11.11%) 
Dizziness  1  1/9 (11.11%) 
Fatigue  1  5/9 (55.56%) 
Headache  1  1/9 (11.11%) 
Insomnia  1  2/9 (22.22%) 
Taste Alteration  1  4/9 (44.44%) 
Hepatobiliary disorders   
Bile duct stenosis  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Anorexia  1  6/9 (66.67%) 
Aspartate Aminotransferase increased  1  1/9 (11.11%) 
Bilirubin increased  1  1/9 (11.11%) 
Blood Glucose Increase  1  4/9 (44.44%) 
Blood uric acid increased  1  1/9 (11.11%) 
Creatinine increased  1  1/9 (11.11%) 
Increased Alkaline Phosphatase  1  5/9 (55.56%) 
Serum Sodium increased  1  1/9 (11.11%) 
Serum magnesium decreased  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Pain(back)  1  2/9 (22.22%) 
Peripheral Sensory Neuropathy  1  2/9 (22.22%) 
Nervous system disorders   
Depression  1  2/9 (22.22%) 
Renal and urinary disorders   
Renal(loss of feeling of urination)  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/9 (44.44%) 
Skin and subcutaneous tissue disorders   
Erythema multiform  1  1/9 (11.11%) 
Vascular disorders   
Thrombosis  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Given the toxicity and lack of objective responses observed with this regimen, the protocol met prospective criteria for early stopping and was terminated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Gauri Varadhachary, MD Associate Professor
Organization: UT MD Adnderson Cancer Center
Phone: 713-792-2828
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416793     History of Changes
Obsolete Identifiers: NCT00409877
Other Study ID Numbers: NCI-2012-02894
NCI-2012-02894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000522739
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-2006-0079 ( Other Identifier: MD Anderson Cancer Network )
7752 ( Other Identifier: CTEP )
First Submitted: December 27, 2006
First Posted: December 28, 2006
Results First Submitted: June 14, 2011
Results First Posted: July 15, 2011
Last Update Posted: May 28, 2014