Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|