Phase 2 N=13 Treatment

Genistein in Treatment of Metastatic Colorectal Cancer

Colon Cancer · Rectal Cancer · Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01985763 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Number of Adverse Events — 250; 119; 24; 0 events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Genistein (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sofya Pintova
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	250; 119; 24; 0	—
PRIMARY Percent Change in Tumor Size	-43.0	—
SECONDARY Response Rate RECIST Criteria	8; 1; 2; 2	—
SECONDARY Number of Participants With an Overall Response Rate (ORR)	6	—
SECONDARY Best Overall Response Rate RECIST Criteria	6; 3; 2; 2	—
SECONDARY Number of Participants With Best Overall Response Rate (ORR)	8	—
SECONDARY Progression Free Survival (PFS)	11.5	—
SECONDARY Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months	69; 38	—
SECONDARY Overall Survival (OS)	36.5	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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
Hematopoietic function
Hemoglobin ≥10g/dL
Absolute Neutrophil Count(ANC) ≥1,500cells/mm2
Platelet Count ≥100,000/µL
Hepatic Function
Total bilirubin ≤ 1.5x the upper limit of normal
ALT and AST must each be ≤2,5x the upper limits of normal
Renal Function
Estimated creatinine clearance (Clcr) ≥30 mL/minute
Are not pregnant and do not plan to become pregnant

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01985763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.