Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
|ClinicalTrials.gov Identifier: NCT01668680|
Recruitment Status : Terminated (No satisfactory acrual)
First Posted : August 20, 2012
Last Update Posted : July 8, 2015
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.
- To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
- To discover predictive factors for response to this LDM regimen.
- The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: CAPECITABINE, CELECOXIB and METHOTREXATE||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: LDM anti-angiogenic chemotherapy
LDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE.
Drug: CAPECITABINE, CELECOXIB and METHOTREXATE
daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE
Other Name: Metronomic Chemotherapy
No Intervention: observation
- Length of progression free survival (PFS), measured in months. [ Time Frame: Up to 12 months. ]From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.
- Toxicity profile of treatment, defined by CTCAE Version 4.0. [ Time Frame: up to12 months ]From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.
- Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1 [ Time Frame: Up to 4 months. ]Change from baseline in levels of angiogenic factors at 4 months of treatment.
- Quality of life, as expressed by FACT-C. [ Time Frame: Up to 12 months. ]Change from baseline in parameters of Quality of life until the end of treatment, assessed up to 12 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668680
|HaEmek Medical Center|
|Afula, Israel, 18101|
|Principal Investigator:||David Loven, MD||Ha'Emek MC|