Study of Individualized Therapies Selection for Patients With Metastatic Colorectal Carcinoma According to the Therapeutic

NCT01703910 | Completed Phase 2 DMC

• 1 other identifier: CNIO-GI-01-2012
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples.

Conditions

Adenocarcinoma of Colon; Adenocarcinoma of Rectum; Metastatic Disease

Keywords

Genomic expression profile in tumor samples; Adult patients; metastatic disease status and progression after two lines of systemic therapy

Outcome Measures

Primary Outcomes (2)

• Overall survival

  To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference

  12 months

• gene expression profiles

  Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.

  12 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Control treatment and will be treated with any of the schemes used in the study according to the discretion of the physician.

Drug: Arm A chemotherapy

Arm B

EXPERIMENTAL

Treatment guided by the gene expression profiles obtained from the CTC

Drug: arm B chemotherapy

Interventions

Arm A chemotherapy DRUG

Also known as: Capecitabine, Cisplatin, Cetuximab, Doxorubicin, Fluorouracil, Gemcitabine, Irinotecan, Topotecan, Mitomycin C, Oxaliplatin, Paclitaxel, Docetaxel, Pemetrexed, Raltitrexed, Sorafenib, Erlotinib, Vinorelbine, Dasatinib, Etoposide

Arm A

arm B chemotherapy DRUG

Also known as: Capecitabine, Cisplatin, Cetuximab, Doxorubicin, Fluorouracil, Gemcitabine, Irinotecan, Topotecan, Mitomycin C, Oxaliplatin, Paclitaxel, Docetaxel, Pemetrexed, Raltitrexed, Sorafenib, Erlotinib, Vinorelbine, Dasatinib, Etoposide

Arm B

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological examination showed of metastatic colon carcinoma.
• Patients more than 18 years.
• Measurable disease according to RECIST 1.1 criteriso
• Life expectancymore than 3 months according to the criteria of the investigator.
• Goodoverall condition determined by the ECOG scale (score 0-1)
• Candidate for systemic treatment based on the profile of sensibility to drugs determined by genetic analysis of the tumor sample. Patients should have received at least two lines of standard treatment, including therapies antiEGFR in cases of tumors with Kras oncogene B-Raf and native (non-mutated).
• Availability of tumor tissue or potential for tumor biopsy correlation allowing the RNA expression profile with that obtained from the peripheral blood CTCs.
• Adequate hematologic function: ANCmore than 1.5 x 103 / L, platelet count absolute more than 100 x 109 / L, normal values of INR and PTT.
• Adequate liver function: total serum bilirubin no more than 2 mg / dL, ALT and AST no more than 3 times the upper limit established by the laboratory (LSR) or no more than 5 LSR in patients with liver metastases.
• Adequate renal function: serum creatinine no more than 1.5 LSR or calculated creatinine clearance 60 ml / min (Crock).

You may not qualify if:

• The patient has received systemic cancer treatment within two weeks prior to extraction of the blood sample.
• Patient has received therapeutic radioisotopes such as strontium 89 within 4 weeks before blood extraction.
• Patient has had major surgery or percutaneous procedures such as placement of central venous catheter within 2 weeks prior to the blood draw.
• Patient has a history as bone marrow transplantation and / or stem cell transplantation.
• Patient has any of the following concomitant diseases or current conditions:
• chronic active liver disease of any origin, and / or cirrhosis with Child-Pugh score B or C.
• Uncontrolled active infection. carries the human immunodeficiency virus (HIV). Any other significant disease that in the opinion of the investigator, substantially increase the risk associated with patient participation in this study.
• documented symptomatic brain metastases, progression or requiring corticosteroids or associated to a leptomeningeal involvement.
• Patients with inability for oral drug delivery, either by preventing gastrointestinal administration situation or severe impairment of intestinal absorption
• Any medical or psychiatric condition that, in the opinion of the investigator, may limit the patient's ability to understand and fulfill all requirements under its partcipación in the study.
• Pregnant or lactating women

Sponsors & Collaborators

• Centro Nacional de Investigaciones Oncologicas CARLOS III: lead
• Hospital Universitario de Fuenlabrada: collaborator
• Grupo Hospital de Madrid: collaborator
• Apices Soluciones S.L.: collaborator

Study Sites (2)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28950, Spain

Location

Hospital Madrid Norte Sanchinarro

Madrid, Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine; Cisplatin; Cetuximab; Doxorubicin; Fluorouracil; Gemcitabine; Irinotecan; Topotecan; Mitomycin; Oxaliplatin; Paclitaxel; Docetaxel; Pemetrexed; raltitrexed; Sorafenib; Erlotinib Hydrochloride; Vinorelbine; Dasatinib; Etoposide

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; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Quinazolines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Thiazoles; Sulfur Compounds; Azoles; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Officials

• Carlos Gómez, M.D.,Ph.D

  Centro Nacional de Investigaciones Oncológicas (CNIO)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2014
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

ES (2)