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

Metastatic Disease Clinical Trial

Official title:

Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703910
• Other study ID #: CNIO-GI-01-2012
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2012
• Last updated: October 8, 2015
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Colon
• Adenocarcinoma of Rectum
• Metastatic Disease
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Rectal Neoplasms

Intervention

Drug:
• Arm A chemotherapy

• arm B chemotherapy

Locations

Country	Name	City	State
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III	Apices Soluciones S.L., Grupo Hospital de Madrid, Hospital Universitario de Fuenlabrada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No