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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: December 7, 2006 to August 26, 2008. All recruitment was done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was terminated early since the protocol met prospective criteria for early stopping.

Reporting Groups
  Description
Bortezomib + Carboplatin 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

Participant Flow:   Overall Study
    Bortezomib + Carboplatin
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bortezomib + Carboplatin 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

Baseline Measures
   Bortezomib + Carboplatin 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Median (Full Range)
 49 
 (49 to 81) 
Gender 
[Units: Participants]
 
Female   2 
Male   7 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures

1.  Primary:   Overall Survival Rate at 6 Months   [ Time Frame: up to 6 months ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Evaluated at end of every second 3 week cycle for response ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Given the toxicity and lack of objective responses observed with this regimen, the protocol met prospective criteria for early stopping and was terminated.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: mjlim@mdanderson.org



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