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Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00754494
First received: September 17, 2008
Last updated: December 22, 2014
Last verified: March 2014
Results First Received: April 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Adenomatous Polyp
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage I Colon Cancer
Stage I Rectal Cancer
Stage IIA Colon Cancer
Stage IIA Rectal Cancer
Stage IIB Colon Cancer
Stage IIB Rectal Cancer
Stage IIC Colon Cancer
Stage IIC Rectal Cancer
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIB Rectal Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Interventions: Drug: erlotinib hydrochloride
Other: placebo
Other: laboratory biomarker analysis

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Arm I (25 mg)

Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Arm II (50 mg)

Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Arm III (100 mg)

Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (25 mg)     Arm II (50 mg)     Arm III (100 mg)  
STARTED     15     15     15  
COMPLETED     13     15     14  
NOT COMPLETED     2     0     1  



  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.
No text entered.

Reporting Groups
  Description
Arm I (25 mg)

Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Arm II (50 mg)

Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Arm III (100 mg)

Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.

erlotinib hydrochloride: Given PO

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Arm I (25 mg)     Arm II (50 mg)     Arm III (100 mg)     Total  
Number of Participants  
[units: participants]
  15     15     15     45  
Age  
[units: years]
Mean ± Standard Deviation
  63.67  ± 4.43     62.47  ± 6.03     60.67  ± 7.42     62.27  ± 6.08  
Gender  
[units: participants]
       
Female     2     1     5     8  
Male     13     14     10     37  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in ACF pERK Levels   [ Time Frame: From baseline to post-treatment (up to 30 days) ]

2.  Secondary:   Change in EGF-inducible Markers - pEGFR in Normal Mucosa   [ Time Frame: From baseline to post-treatment (up to 30 days) ]

3.  Secondary:   Change in EGF-inducible Markers - Total EGFR in Normal Mucosa   [ Time Frame: From baseline to post-treatment (up to 30 days) ]

4.  Secondary:   Change in EGF-inducible Markers - pEGFR in ACF   [ Time Frame: From baseline to post-treatment (up to 30 days) ]

5.  Secondary:   Change in EGF-inducible Markers - Total EGFR in ACF   [ Time Frame: From baseline to post-treatment (up to 30 days) ]

6.  Secondary:   ACF: Normal Mucosa pERK Ratio   [ Time Frame: Up to day 30 ]

7.  Secondary:   Plasma Erlotinib Concentration (ng/mL)   [ Time Frame: Up to day 30 ]

8.  Secondary:   Plasma OSI-420 Concentration (ng/mL)   [ Time Frame: Up to day 30 ]

9.  Secondary:   Normal Mucosa Erlotinib Concentration (ng/mg)   [ Time Frame: Up to day 30 ]

10.  Secondary:   Normal Mucosa OSI-420 Concentration (ng/mg)   [ Time Frame: Up to day 30 ]

11.  Secondary:   Number of Participants Reported at Least 1 Side Effect During the Study   [ Time Frame: Up to 9 weeks ]

12.  Secondary:   Number of Participants Reported at Least 1 Rash Side Effect During the Study   [ Time Frame: Up to 9 weeks ]

13.  Secondary:   Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study   [ Time Frame: Up to 9 weeks ]


  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: Dr. Timothy R. Morgan
Organization: University of California, Irvine
phone: 562-826-5756
e-mail: timothy.morgan@va.gov


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00754494     History of Changes
Other Study ID Numbers: NCI-2012-02984, UCI06-8-01, N01CN35160, CDR0000614277
Study First Received: September 17, 2008
Results First Received: April 23, 2014
Last Updated: December 22, 2014
Health Authority: United States: Food and Drug Administration