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Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Genentech, Inc.
Information provided by (Responsible Party):
Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00307736
First received: March 24, 2006
Last updated: March 30, 2017
Last verified: March 2017
Results First Received: January 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Rectal Cancer
Adenocarcinoma of the Rectum
Interventions: Drug: 5-fluorouracil
Drug: bevacizumab
Drug: erlotinib
Procedure: External beam radiation therapy (EBRT)

  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
This is a single center (institutions comprising Dana Farber Partners/Harvard Cancer Center) trial. Subjects were selected upon referral to the respective clinics of the investigators’ institution. Patients Patients were enrolled on to the study between May 2006 and December 2009.

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
Phase 1 (Erlotinib 50mg)

Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.

5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.

bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.

erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.

External beam radiation therapy (EBRT): Given on days 1-5 and 8-12

Phase 1 (100mg Erlotinib)

Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.

5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.

bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.

erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.

External beam radiation therapy (EBRT): Given on days 1-5 and 8-12

Phase 1 (150mg Erlotinib)

Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.

5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.

bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.

erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.

External beam radiation therapy (EBRT): Given on days 1-5 and 8-12

Phase II (100mg Erlotinib)

Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.

5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.

bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.

erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.

External beam radiation therapy (EBRT): Given on days 1-5 and 8-12


Participant Flow:   Overall Study
    Phase 1 (Erlotinib 50mg)   Phase 1 (100mg Erlotinib)   Phase 1 (150mg Erlotinib)   Phase II (100mg Erlotinib)
STARTED   3   3   3   23 
COMPLETED   3   3   0   20 
NOT COMPLETED   0   0   3   3 
Adverse Event                0                0                1                3 
Withdrawal by Subject                0                0                2                0 



  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
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.

Baseline Measures
   5-fluorocuracil, Bevacizumab, Erlotinib and Radiation 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      28  87.5% 
>=65 years      4  12.5% 
Age 
[Units: Years]
Mean (Full Range)
 53.5 
 (35 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  25.0% 
Male      24  75.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      28  87.5% 
Not Hispanic or Latino      2   6.3% 
Unknown or Not Reported      2   6.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   29 
Other   3 
Region of Enrollment 
[Units: Participants]
 
United States   32 
Stage Grouping [1] 
[Units: Participants]
Count of Participants
 
II   11 
III   21 
[1] The cancer is referred to as Stage II rectal cancer if the pathology report shows that the cancer has penetrated the wall of the rectum, but does not invade any of the local lymph nodes and cannot be detected in other locations in the body The cancer is referred to as Stage III rectal cancer if the pathology report shows that the cancer has invaded any of the local lymph nodes, but cannot be detected in other locations in the body.
Clinical staging [1] 
[Units: Participants]
Count of Participants
 
T3N0   6 
T3N1   15 
T3N2M0   4 
T3Nx   4 
T4N0   2 
T4N1   1 
[1] MRI or ultrasound determined T stage. Clinical staging is based off of TNM staging (Tumor, Node, Metastasis). The "T" and the following number (0 to 4) are used to describe how deeply the primary tumor has grown into the bowel lining (Tx: primary tumor cannot be evaluated, Tis: refers to carcinoma in situ). The "N" stands for lymph nodes: (Nx: regional lymph nodes cannot be evaluated; N0: no spread to regional lymph nodes; N1: tumor cells found in 1-3 regional lymph nodes; N2: tumor cells found in 4-7 regional lymph nodes). M0: the disease has not spread to a distant part of the body.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy   [ Time Frame: 3 years ]

2.  Secondary:   Summary of Grade 3 or Greater Toxicity   [ Time Frame: 3 years ]

3.  Secondary:   Percentage of Participants With Disease-free Survival   [ Time Frame: 1, 2, 3 years ]

4.  Secondary:   Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.   [ Time Frame: 3 years ]

5.  Other Pre-specified:   Pathologic Complete Response   [ Time Frame: 3 years ]


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


Results Point of Contact:  
Name/Title: Lawrence Blaszkowsky
Organization: Massachusetts General Hospital
phone: 6177244637
e-mail: lblaszkowsky@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00307736     History of Changes
Other Study ID Numbers: 05-345
Study First Received: March 24, 2006
Results First Received: January 27, 2017
Last Updated: March 30, 2017