Skip to main content
OpenTrials
Completed

NCT Number: NCT01985763

Genistein in Treatment of Metastatic Colorectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genistein

Drug

Genistein combined with FOLFOX or FOLFOX-Avastin

Other names: Bonistein

Primary outcomes

  1. Number of Adverse Events

    Time frame: up to 6 months

    Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.

  2. Percent Change in Tumor Size

    Time frame: end of Cycle 6

    Percent change in tumor size after cycle 6. Each cycle is 21 days.

Secondary outcomes

  1. Response Rate RECIST Criteria

    Time frame: end of Cycle 6

    Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  2. Number of Participants With an Overall Response Rate (ORR)

    Time frame: up to 50 months

    Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period

  3. Best Overall Response Rate RECIST Criteria

    Time frame: up to 50 months

    Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

    SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions.

    PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions.

  4. Number of Participants With Best Overall Response Rate (ORR)

    Time frame: up to 50 months

    The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

  5. Progression Free Survival (PFS)

    Time frame: up to 50 months

    Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

  6. Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months

    Time frame: 6 month and 12 month

    Patients monitored for progression during the study period and 1 year following.

    Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

  7. Overall Survival (OS)

    Time frame: up to 50 months

    Overall Survival - Number of months still living since baseline

Sponsors and collaborators

Lead sponsor

Sofya Pintova

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

Genistein Combined With FOLFOX or FOLFOX-Avastin for Treatment of Metastatic Colorectal Cancer: Phase I/II Pilot Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 15, 2013
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.