Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sofya Pintova
With
dsm-firmenich Switzerland AG
OBJECTIVES:
Primary
* Evaluate the tolerability of genistein when combined with chemotherapy
Secondary:
* Evaluate Response Rate (RR) as measured by the radiologic RECIST criteria
* Evaluate Progression Free Survival (PFS)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult male and female patients ≥18 years old
Have pathologically confirmed colon or rectal carcinoma
Have metastatic (stage IV) disease
Have a plan by treating physician to receive FOLFOX or FOLFOX-Avastin
Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Have adequate hematopoietic, hepatic and renal function
1. Hematopoietic function
* Hemoglobin ≥10g/dL
* Absolute Neutrophil Count(ANC) ≥1,500cells/mm2
* Platelet Count ≥100,000/µL
2. Hepatic Function
* Total bilirubin ≤ 1.5x the upper limit of normal
* ALT and AST must each be ≤2,5x the upper limits of normal
Are not pregnant and do not plan to become pregnant
You may not be if
Prior systemic chemotherapy for metastatic disease
History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
Patients taking MAO-inhibitors
History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
Unable to give informed consent or comply with clinical trial requirements
Uncontrolled hypertension
History of clinically significant GI bleeding within prior 2 months prior to enrollment
Presence of GI fistula
Prior history of bowel perforation
History of CNS thrombotic/embolic or ischemic events
Have past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with the follow up visits.
Clareo Health | Genistein in Treatment of Metastatic Colorectal Cancer
