Genistein in Treatment of Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT01985763|
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : January 27, 2017
Colorectal neoplasms are the third most common malignancies in the United States. Patients with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The response rates to chemotherapy range from 35-40%.
Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-Fluorouracil and platinum compounds.
Based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. The aim of the study is to add genistein to the regimens of FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer Colorectal Cancer||Drug: Genistein||Phase 1 Phase 2|
- Evaluate the tolerability of genistein when combined with chemotherapy
- Evaluate Response Rate (RR) as measured by the radiologic RECIST criteria
- Evaluate Progression Free Survival (PFS)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genistein Combined With FOLFOX or FOLFOX-Avastin for Treatment of Metastatic Colorectal Cancer: Phase I/II Pilot Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 19, 2017|
|Actual Study Completion Date :||January 19, 2017|
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein will be administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Genistein combined with FOLFOX or FOLFOX-Avastin
Other Name: Bonistein
- tolerability of genistein treatment [ Time Frame: up to 6 months ]Evaluation of side effects will be conducted every 14 days before each chemotherapy/genistein cycle. Side effects will be evaluated by a brief survey.
- Response Rate (RR) CEA [ Time Frame: up to 18 months ]Response Rate (RR) as measured by radiologic RECIST criteria. Restaging will be done by the treating physician as part of standard of care. CEA and radiographic restaging maybe triggered by clinical changes or routine follow up. Standard of care is CEA every 6 weeks.
- Response Rate (RR) imaging [ Time Frame: up to 18 months ]Response Rate (RR) as measured by radiologic RECIST criteria. Restaging will be done by the treating physician as part of standard of care. CEA and radiographic restaging maybe triggered by clinical changes or routine follow up. Standard of care is radiographic imaging every 3 months.
- Progression Free Survival (PFS) [ Time Frame: up to 18 months ]Patients will be monitored for progression during the study period and 1 year following.
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): NCT01985763
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Randall F Holcombe, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Sofya Pintova, MD||Icahn School of Medicine at Mount Sinai|