Genistein in Treatment of Metastatic Colorectal Cancer

NCT ID: NCT01985763

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-10-31

Brief 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.

Detailed Description

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)

Conditions

Colon Cancer; Rectal Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genistein

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.

Group Type: EXPERIMENTAL

Genistein

Intervention Type: DRUG

Genistein combined with FOLFOX or FOLFOX-Avastin

Interventions

Genistein

Genistein combined with FOLFOX or FOLFOX-Avastin

Intervention Type: DRUG

Other Intervention Names

Bonistein

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

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

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Sofya Pintova

OTHER

Sponsor Role: lead

Responsible Party

Sofya Pintova

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Randall F Holcombe, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Sofya Pintova, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GCO 13-1697

Identifier Type: -

Identifier Source: org_study_id