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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Centro Nacional de Investigaciones Oncologicas CARLOS III.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Universitario de Fuenlabrada
Grupo Hospital de Madrid
Apices Soluciones S.L.
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier:
NCT01703910
First received: October 8, 2012
Last updated: January 21, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of Colon
Adenocarcinoma of Rectum
Metastatic Disease
Drug: Arm A chemotherapy
Drug: arm B chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.

Resource links provided by NLM:


Further study details as provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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

  • gene expression profiles [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
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
Other Names:
  • Capecitabine
  • Cisplatin
  • Cetuximab
  • Doxorubicin
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Topotecan
  • Mitomycin C
  • Oxaliplatin
  • Paclitaxel
  • Docetaxel
  • Pemetrexed
  • Raltitrexed
  • Sorafenib
  • Erlotinib
  • Vinorelbine
  • Dasatinib
  • Etoposide
Experimental: Arm B
Treatment guided by the gene expression profiles obtained from the CTC
Drug: arm B chemotherapy
Other Names:
  • Capecitabine
  • Cisplatin
  • Cetuximab
  • Doxorubicin
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Topotecan
  • Mitomycin C
  • Oxaliplatin
  • Paclitaxel
  • Docetaxel
  • Pemetrexed
  • Raltitrexed
  • Sorafenib
  • Erlotinib
  • Vinorelbine
  • Dasatinib
  • Etoposide

Detailed Description:

It is a prospective, randomized study in patients with metastatic colorectal carcinoma progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive chemotherapy as determined by its oncologist or treatment according to chemosensitivity profile obtained. For obtaining the profile a histological tumor sample and a sample of venous blood in a tube with heparin standard are necessary . This latter sample will be processed to isolate circulating tumor cells by cell adhesion with matrix coated glass spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor biopsies from the same patients will be extracted by a standard procedure for extracting RNA for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated a ranked list of potentially more effective treatments in every case

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 uncontrolled systemic diseases. Patients with Hypertension or Diabetes Mellitus is countable if at the time of inclusion deemed medically controlled.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703910

Contacts
Contact: Antonio López, Biologist 91 600 60 28 alopeza@cnio.es
Contact: Laura Ledesma, Nurse, Study Coordinator 91 600 65 84 lledesma@ext.cnio.es

Locations
Spain
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28950
Contact: Antonio López, Biologist    91 600 60 28    alopeza@cnio.es   
Contact: Laura Ledesma, Nurse, Study Coordinator    91 600 65 84    lledesma@ext.cnio.es   
Principal Investigator: Carlos Gómez, MD., PhD         
Sub-Investigator: Elena Garralda, M.D.         
Sub-Investigator: Ignacio Juez, M.D., PhD         
Sub-Investigator: Manuel Hidalgo, M.D.,Ph.D         
Hospital Madrid Norte Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Gemma Sánchez, Study Coordinator    (+34) 91 756 79 84    gsanchez@fundacionhm.com   
Contact: Fátima Solís, Data Manager    (+34) 91 756 79 84    fatimasolis@hospitaldemadrid.com   
Principal Investigator: Antonio Cubillo, M.D.,Ph.D         
Sub-Investigator: Jesús Rodríguez, M.D., Ph.D         
Sponsors and Collaborators
Centro Nacional de Investigaciones Oncologicas CARLOS III
Hospital Universitario de Fuenlabrada
Grupo Hospital de Madrid
Apices Soluciones S.L.
Investigators
Study Director: Carlos Gómez, M.D.,Ph.D Centro Nacional de Investigaciones Oncológicas (CNIO)
  More Information

No publications provided

Responsible Party: Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier: NCT01703910     History of Changes
Other Study ID Numbers: CNIO-GI-01-2012
Study First Received: October 8, 2012
Last Updated: January 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:
Genomic expression profile in tumor samples
Adult patients
metastatic disease status and progression after two lines of systemic therapy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Rectal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Mitomycins
Mitomycin
Doxorubicin
Gemcitabine
Oxaliplatin
Vinorelbine
Irinotecan
Raltitrexed
Docetaxel
Pemetrexed

ClinicalTrials.gov processed this record on July 23, 2014