Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients

NCT01453257 | Completed Phase 2

• 1 other identifier: C62 202-878
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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%.

Conditions

Progression Free Survival

Keywords

Molecular Targets; Personalize Treatment; Colon Cancer; Complete Response Rate

Outcome Measures

Primary Outcomes (1)

• PFS

  12 months

Secondary Outcomes (1)

• Complete Response Rate

  12 months

Study Arms (1)

Chemotherapy treatment

EXPERIMENTAL

Tailored chemotherapy by Therapeutic Targets

Drug: Tailored Chemotherapy

Interventions

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

Also known as: Biomarker selection, Therapeutic Targets chemotherapy

Chemotherapy treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
• Previous Chemotherapy treatment

Sponsors & Collaborators

• Grupo Hospital de Madrid: lead

Study Sites (1)

Centro Integral Oncológico Clara campal

Madrid, Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Antonio Cubillo, Md PhD

  Grupo Hospital madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fundación Hospital de mADRID

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

ES (1)