Back to resultsStudy of Target-Guided Chemotherapy in Metastatic Colorectal Patients (TT)
Primary Purpose
Progression Free Survival
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Tailored Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Progression Free Survival focused on measuring Molecular Targets, Personalize Treatment, Colon Cancer, Complete Response Rate
Eligibility Criteria
Inclusion Criteria:
- Colorectal adenocarcinoma stage IV patients.
- ECOG= 0-1
- Age > 18 years.
- Fit to receive chemotherapy treatment
- Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
- Adequate renal (Cr < 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)
Exclusion Criteria:
- Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
- Previous Chemotherapy treatment
Sites / Locations
- Centro Integral Oncológico Clara campal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy treatment
Arm Description
Tailored chemotherapy by Therapeutic Targets
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
Complete Response Rate
Full Information
NCT ID
NCT01453257
First Posted
October 13, 2011
Last Updated
October 18, 2011
Sponsor
Grupo Hospital de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT01453257
Brief Title
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
Acronym
TT
Official Title
A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Hospital de Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.
The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression Free Survival
Keywords
Molecular Targets, Personalize Treatment, Colon Cancer, Complete Response Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy treatment
Arm Type
Experimental
Arm Description
Tailored chemotherapy by Therapeutic Targets
Intervention Type
Drug
Intervention Name(s)
Tailored Chemotherapy
Other Intervention Name(s)
Biomarker selection, Therapeutic Targets chemotherapy
Intervention Description
Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by:
K-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU
Primary Outcome Measure Information:
Title
PFS
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complete Response Rate
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal adenocarcinoma stage IV patients.
ECOG= 0-1
Age > 18 years.
Fit to receive chemotherapy treatment
Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
Adequate renal (Cr < 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)
Exclusion Criteria:
Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
Previous Chemotherapy treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cubillo, Md PhD
Organizational Affiliation
Grupo Hospital madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Integral Oncológico Clara campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
We'll reach out to this number within 24 hrs