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Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients

NCT ID: NCT01453257

Last Updated: 2011-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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%.

Detailed Description

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Conditions

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Progression Free Survival

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy treatment

Tailored chemotherapy by Therapeutic Targets

Group Type EXPERIMENTAL

Tailored Chemotherapy

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Biomarker selection Therapeutic Targets chemotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Hospital de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Sofia Perea, PharmD, PhD

Fundación Hospital de mADRID

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Cubillo, Md PhD

Role: PRINCIPAL_INVESTIGATOR

Grupo Hospital madrid

Locations

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Centro Integral Oncológico Clara campal

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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C62 202-878

Identifier Type: -

Identifier Source: org_study_id