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Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients (TT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sofia Perea, PharmD, PhD, Grupo Hospital de Madrid
ClinicalTrials.gov Identifier:
NCT01453257
First received: October 13, 2011
Last updated: October 18, 2011
Last verified: October 2011
History of Changes

October 13, 2011
October 18, 2011
October 2009
October 2011   (final data collection date for primary outcome measure)
PFS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01453257 on ClinicalTrials.gov Archive Site
Complete Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients

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%.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Progression Free Survival
Drug: Tailored Chemotherapy

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

Other Names:
  • Biomarker selection
  • Therapeutic Targets chemotherapy
Experimental: Chemotherapy treatment
Tailored chemotherapy by Therapeutic Targets
Intervention: Drug: Tailored Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01453257
C62 202-878
No
Sofia Perea, PharmD, PhD, Grupo Hospital de Madrid
Grupo Hospital de Madrid
Not Provided
Principal Investigator: Antonio Cubillo, Md PhD Grupo Hospital madrid
Grupo Hospital de Madrid
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP