Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients

Progression Free Survival Clinical Trial

— TT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453257
• Other study ID #: C62 202-878
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2011
• Last updated: October 18, 2011
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Grupo Hospital de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Progression Free Survival

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Integral Oncológico Clara campal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Hospital de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		12 months	No
Secondary	Complete Response Rate		12 months	No