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OpenTrials
Completed

NCT Number: NCT01453257

Study of Target-Guided Chemotherapy in Metastatic Colorectal 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%.

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Key information

Conditions

Progression Free Survival Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Integral Oncológico Clara campal

Madrid, 28050, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Chemotherapy

Drug

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

Primary outcomes

  1. PFS

    Time frame: 12 months

Secondary outcomes

  1. Complete Response Rate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Grupo Hospital de Madrid

Other

Registry information

Official study title

A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients

Acronym: TT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2011
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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