Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00577889
First received: December 19, 2007
Last updated: September 20, 2013
Last verified: September 2013
Results First Received: September 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions: Drug: gemcitabine hydrochloride
Drug: tanespimycin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 21 patients were accrued from May 30, 2008 to September 2, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 21 patients were accrued and randomized onto one of 3 parallel arms (Arm I: 9 patients; Arm II: 6 patients; Arm III: 6 patients). One patient from Arm I canceled and was not used in baseline analysis nor endpoint analysis.

Reporting Groups
  Description
Arm I (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Arm II (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Arm III (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.

Participant Flow:   Overall Study
    Arm I (Combination Chemotherapy)     Arm II (Combination Chemotherapy)     Arm III (Combination Chemotherapy)  
STARTED     9     6     6  
COMPLETED     8     6     6  
NOT COMPLETED     1     0     0  
Withdrawal by Subject                 1                 0                 0  



  Baseline Characteristics
  Hide 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.
One patient in Arm I canceled prior to treatment and was not used in baseline summary.

Reporting Groups
  Description
Arm I (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Arm II (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Arm III (Combination Chemotherapy) Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Total Total of all reporting groups

Baseline Measures
    Arm I (Combination Chemotherapy)     Arm II (Combination Chemotherapy)     Arm III (Combination Chemotherapy)     Total  
Number of Participants  
[units: participants]
  8     6     6     20  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 51 to 77 )  
  71  
  ( 51 to 81 )  
  67  
  ( 55 to 75 )  
  61.5  
  ( 51 to 81 )  
Gender  
[units: participants]
       
Female     3     2     4     9  
Male     5     4     2     11  
Region of Enrollment  
[units: participants]
       
United States     8     6     6     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Six Month Survival Rate   [ Time Frame: 6 months ]

2.  Secondary:   Overall Survival Time   [ Time Frame: Assessed up to 2 years from registration ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Time from registration to documentation of disease progression, assessed up to 2 years ]

4.  Secondary:   Confirmed Response Rate   [ Time Frame: 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Robert McWilliams, M.D.
Organization: Mayo Clinic Cancer Center
e-mail: McWilliams.robert@mayo.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00577889     History of Changes
Obsolete Identifiers: NCT01647022
Other Study ID Numbers: NCI-2009-00156, MC0542, CDR0000445454, N01CM17104
Study First Received: December 19, 2007
Results First Received: September 20, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration