Low Dose Metronomic Poly-chemotherapy for Metastatic CRC (LDMchemoCRC)
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|ClinicalTrials.gov Identifier: NCT02280694|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Capecitabine Drug: Cyclophosphamide Drug: Methotrexate Drug: Celecoxib||Phase 2|
Patients suffering from metastases of colorectal cancer whose tumor cells develop resistance to conventionally administered treatments are in need for new methods of treatment.
While their chemotherapy had been administered up till then at the classical regimen of Maximal Tolerated Doses (MTD), which is aimed to directly killing maximal fractions of tumor cells, the present study evaluates the clinical benefit of a treatment which is based on old chemotherapeutic and old anti-inflammatory drugs, when these are administered at low doses,on daily basis and orally taken, without planed brakes (Low Dose Metronomic regimen).
Treatments based on this type of regimen have already been studied on other models of cancer and showed the capacity of suppressing tumor growth by a new category of anti-tumor effects. Namely, by affecting factors and mechanisms which prevail in the microenvironment that surrounds tumor deposits, thus circumventing the resistance of their cancer cells to chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metronomic Poly-chemotherapy for Metastatic Colorectal Cancer at Progression Following Established Treatments: Clinical and Laboratory Research|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||December 2019|
Experimental: capecitabine, cyclophosphamide, methotrexate, celecoxib
The Investigational Product: Route and Dosage Form Ambulatory/oral, continuous but not uniform, DAILY treatment
Other Name: Xeloda
Other Name: Endoxan
Other Name: Abitrexate, Methotrexat "Ebewe", Metoject medac
Other Name: Celebra, Celcox
- The median progression free survival (mPFS) [ Time Frame: Base line and every consecutive 8 weeks, up to disease progression or exit from study for any other cause, up to 18 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): NCT02280694
|Gastrointestinal Oncology Unit, Institute of Oncology, Davidoff Center, Rabin Medical Center, Belinson Campus,|
|Petach Tiqva, Israel|
|Principal Investigator:||Ofer Purim, MD||Gastrointestinal Oncology Unit, Institute of Oncology, Davidoff Center, Rabin Medical Center, Belinson Campus, Petach Tiqva, Israel|