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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Progression Free Survival

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PFS

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Antonio Cubillo, Md PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Grupo Hospital madrid

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

C62 202-878

NCT ID:

NCT01453257

Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Progression Free Survival
  • Molecular Targets
  • Personalize Treatment
  • Colon Cancer
  • Complete Response Rate

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