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Genistein in Treatment of Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Sofya Pintova, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01985763
First received: November 9, 2013
Last updated: January 25, 2017
Last verified: January 2017
  Purpose

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 Intervention Phase
Colon Cancer Rectal Cancer Colorectal Cancer Drug: Genistein Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genistein Combined With FOLFOX or FOLFOX-Avastin for Treatment of Metastatic Colorectal Cancer: Phase I/II Pilot Study

Resource links provided by NLM:


Further study details as provided by Sofya Pintova, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 13
Study Start Date: November 2013
Study Completion Date: January 19, 2017
Primary Completion Date: January 19, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Genistein
Genistein combined with FOLFOX or FOLFOX-Avastin
Other Name: Bonistein

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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985763

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Sofya Pintova
DSM Nutritional Products, Inc.
Investigators
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
  More Information

Publications:
Helms JR and Gallaher DD, The effect of dietary soy protein isolate and genistein on the development of preneoplastic lesions (aberrant crypts) in rats. 1995 Cancer Lett:125
Yanhong H, et al, Genistein sensitizes ovarian carcinoma cells to chemotherapy by switching the cell cycle progression in vitro. J Medical Colleges of PLA:125-135

Responsible Party: Sofya Pintova, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01985763     History of Changes
Other Study ID Numbers: GCO 13-1697
Study First Received: November 9, 2013
Last Updated: January 25, 2017

Keywords provided by Sofya Pintova, Icahn School of Medicine at Mount Sinai:
Genistein
soy supplements
phytoestrogens
colon cancer
rectal cancer
colorectal cancer
metastatic
stage IV
FOLFOX
FOLFOX-Avastin
Chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Genistein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 18, 2017