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New Individualized Therapy Trial for Metastatic Colorectal Cancer (NITMEC)

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ClinicalTrials.gov Identifier: NCT00867334
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Inova Health Care Services

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Neoplasm
Colorectal Cancer
Interventions Drug: Imatinib mesylate and panitumumab
Drug: Standard-of-care treatment with panitumumab
Enrollment 10
Recruitment Details Patients were enrolled at community hospital.
Pre-assignment Details Inclusion and exclusion criteria for the study were rigid, with only 10 patients of 39 screens being able to enroll. Of these 10 patients, 3 were subsequent screen failures thus did not continue in the study.
Arm/Group Title Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Hide Arm/Group Description

Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.

All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.

Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
Period Title: Overall Study
Started 6 1
Completed 4 0
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             0             1
Withdrawal by Subject             1             0
Physician Decision             1             0
Arm/Group Title Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab Total
Hide Arm/Group Description

Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.

All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.

Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment. Total of all reporting groups
Overall Number of Baseline Participants 6 1 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 1 participants 7 participants
58.7  (7.9) 72  (0) 60.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 1 participants 7 participants
Female
4
  66.7%
1
 100.0%
5
  71.4%
Male
2
  33.3%
0
   0.0%
2
  28.6%
1.Primary Outcome
Title Number of Patients With Adverse Events
Hide Description Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected and recorded.
Time Frame From consent up until 4 weeks after patient has stopped study participation
Hide Outcome Measure Data
Hide Analysis Population Description
The subject randomized to the "Standard of Care Therapy with Panitumumab arm" withdrew after randomization, so no data was collected.
Arm/Group Title Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Hide Arm/Group Description:

Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.

All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.

Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
Overall Number of Participants Analyzed 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
5
  83.3%
0
2.Secondary Outcome
Title Number of Participants With Stabilization or Reduction in Tumor Size
Hide Description Results reported as number of patients with stabilization or reduction in tumor size. Tumor response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) solid tumor response criteria, evaluated by CT.
Time Frame 8 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
CT measurements of metastasis were planned through timepoint 3 (24 weeks). One participant only had data at timepoint 1 (8 weeks), so timepoint 1 was chosen as the post-treatment comparison timepoint for all participants. One subject in the imatinib group and one subject in the panitumumab group withdrew before obtaining 8 week evaluations.
Arm/Group Title Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Hide Arm/Group Description:

Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.

All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.

Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
Overall Number of Participants Analyzed 5 0
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
0
Time Frame Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Adverse Event Reporting Description Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
 
Arm/Group Title Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Hide Arm/Group Description

Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.

All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.

Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
All-Cause Mortality
Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      0/0    
Cardiac disorders     
Hypotension *  1/6 (16.67%)  1 0/0  0
Gastrointestinal disorders     
Dehydration *  1/6 (16.67%)  1 0/0  0
General disorders     
Hemorrhage/Bleeding *  1/6 (16.67%)  1 0/0  0
Infections and infestations     
Infection *  1/6 (16.67%)  1 0/0  0
Renal and urinary disorders     
Renal failure *  1/6 (16.67%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment With Increasing Doses of Imatinib Standard of Care Therapy With Panitumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      0/0    
Blood and lymphatic system disorders     
Edema *  4/6 (66.67%)  9 0/0  0
White Blood Count *  1/6 (16.67%)  3 0/0  0
Cardiac disorders     
Hypotension *  1/6 (16.67%)  1 0/0  0
Gastrointestinal disorders     
Vomiting *  2/6 (33.33%)  2 0/0  0
Diarrhea *  3/6 (50.00%)  4 0/0  0
Nausea *  2/6 (33.33%)  2 0/0  0
Dehydration *  2/6 (33.33%)  2 0/0  0
Anorexia *  1/6 (16.67%)  1 0/0  0
Mucositis *  1/6 (16.67%)  1 0/0  0
Anal Incontinence *  1/6 (16.67%)  1 0/0  0
Distension *  1/6 (16.67%)  1 0/0  0
Constipation *  1/6 (16.67%)  1 0/0  0
General disorders     
Pain *  2/6 (33.33%)  5 0/0  0
Weakness *  1/6 (16.67%)  1 0/0  0
Generalized aches and pain *  1/6 (16.67%)  1 0/0  0
Creatinine *  1/6 (16.67%)  8 0/0  0
Alkaline Phosphatase *  3/6 (50.00%)  21 0/0  0
Alanine aminotransferease *  3/6 (50.00%)  8 0/0  0
Hemoglobin *  3/6 (50.00%)  11 0/0  0
Fever *  1/6 (16.67%)  2 0/0  0
Total Bilirubin *  1/6 (16.67%)  3 0/0  0
Aspartate aminotransferase *  2/6 (33.33%)  6 0/0  0
Hypokalemia *  1/6 (16.67%)  1 0/0  0
Proteinuria *  1/6 (16.67%)  1 0/0  0
Weight loss *  1/6 (16.67%)  1 0/0  0
Rigors/chills *  1/6 (16.67%)  1 0/0  0
Fatigue *  1/6 (16.67%)  1 0/0  0
Absolute neutrophil count *  1/6 (16.67%)  1 0/0  0
Platelets *  1/6 (16.67%)  2 0/0  0
Glucose *  1/6 (16.67%)  2 0/0  0
Dizziness *  1/6 (16.67%)  1 0/0  0
Albumin *  1/6 (16.67%)  8 0/0  0
Hepatobiliary disorders     
Liver dysfunction *  1/6 (16.67%)  2 0/0  0
Hepatomegaly *  1/6 (16.67%)  1 0/0  0
Renal and urinary disorders     
Infection *  2/6 (33.33%)  2 0/0  0
Hematuria *  1/6 (16.67%)  1 0/0  0
Urinary retention *  2/6 (33.33%)  2 0/0  0
Stool in urine *  1/6 (16.67%)  3 0/0  0
Fistula - bladder and rectum *  1/6 (16.67%)  1 0/0  0
Reproductive system and breast disorders     
Hemorrhage GU - Vaginal *  1/6 (16.67%)  1 0/0  0
Skin and subcutaneous tissue disorders     
Rash or injection site reaction *  3/6 (50.00%)  12 0/0  0
Priuritus/itching *  1/6 (16.67%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
This is a pilot study utilizing only a small sample size of people.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emanuel Petricoin
Organization: George Mason University
Phone: 571-830-4166
EMail: epetrico@gmu.edu
Layout table for additonal information
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT00867334     History of Changes
Other Study ID Numbers: CSTI571BUS278T
First Submitted: March 19, 2009
First Posted: March 23, 2009
Results First Submitted: January 4, 2016
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019