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Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

NCT01668680 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-07-08

No results posted yet for this study

Summary

Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment.

Objectives:

1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
2. To discover predictive factors for response to this LDM regimen.

Hypothesis:

1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

CAPECITABINE, CELECOXIB and METHOTREXATE

daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE

Sponsors & Collaborators

  • Clalit Health Services

    collaborator OTHER

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • David Loven, MD · Ha'Emek MC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668680 on ClinicalTrials.gov