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

Phase 2
18 Years
76 Years
Open (Enrolling)
Adenocarcinoma of Colon, Adenocarcinoma of Rectum, Metastatic Disease

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Trial Information

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

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

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

- 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

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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Carlos Gómez, M.D.,Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Centro Nacional de Investigaciones Oncológicas (CNIO)


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

November 2012

Completion Date:

September 2013

Related Keywords:

  • Adenocarcinoma of Colon
  • Adenocarcinoma of Rectum
  • Metastatic Disease
  • Genomic expression profile in tumor samples
  • Adult patients
  • metastatic disease status and progression after two lines of systemic therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Rectal Neoplasms
  • Colonic Neoplasms