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Trial record 1 of 1 for:    ACOSOG Z5041
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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
OSI Pharmaceuticals
Astellas Pharma Inc
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00733746
First received: August 12, 2008
Last updated: May 23, 2017
Last verified: May 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Procedure: therapeutic conventional surgery

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
123 patients enrolled to this study. 4 patients cancelled prior to treatment and were not included in any analysis.

Reporting Groups
  Description
Neoadjuvant Therapy + Surgery + Adjuvant Therapy

Neoadjuvant Therapy:

As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.

Surgery:

Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.

Adjuvant Therapy:

Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.


Participant Flow:   Overall Study
    Neoadjuvant Therapy + Surgery + Adjuvant Therapy
STARTED   119 
COMPLETED   114 
NOT COMPLETED   5 
Ineligible                5 



  Baseline Characteristics
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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.
All patients that started protocol treatment were included in this analysis.

Reporting Groups
  Description
Neoadjuvant Therapy + Surgery + Adjuvant Therapy

Neoadjuvant Therapy:

As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.

Surgery:

Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.

Adjuvant Therapy:

Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.


Baseline Measures
   Neoadjuvant Therapy + Surgery + Adjuvant Therapy 
Overall Participants Analyzed 
[Units: Participants]
 119 
Age 
[Units: Years]
Median (Full Range)
 66 
 (39 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      58  48.7% 
Male      61  51.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
Canada   19 
United States   100 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival at 2 Years   [ Time Frame: At 2 years post-registration ]

2.  Secondary:   Resection Rate   [ Time Frame: Up to 4 years postoperative chemotherapy treatment ]

3.  Secondary:   Relapse/Progression-free Survival   [ Time Frame: At 2 years post-registration ]

4.  Secondary:   Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI’s Common Toxicity Criteria for Adverse Events   [ Time Frame: Up to 4 years postoperative chemotherapy treatment ]

5.  Secondary:   Response Rate   [ Time Frame: Up to 4 years postoperative chemotherapy treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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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: Peter Pisters, MD
Organization: Alliance for Clinical Trials in Oncology
e-mail: ppisters@mdanderson.org



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00733746     History of Changes
Other Study ID Numbers: ACOSOG-Z5041
U10CA076001 ( U.S. NIH Grant/Contract )
NCI-2009-00348 ( Other Identifier: NCI Clinical Trial Reporting Office )
CDR0000609871 ( Registry Identifier: NCI Physician Data Query )
Study First Received: August 12, 2008
Results First Received: March 28, 2017
Last Updated: May 23, 2017