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Genistein in Treatment of Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01985763
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Sofya Pintova, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colon Cancer
Rectal Cancer
Colorectal Cancer
Intervention Drug: Genistein
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Genistein
Hide Arm/Group Description Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Genistein
Hide Arm/Group Description Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
61
(32 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  15.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   7.7%
White
3
  23.1%
More than one race
0
   0.0%
Unknown or Not Reported
7
  53.8%
ECOG   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
0
8
  61.5%
1
5
  38.5%
[1]
Measure Description:

The Eastern Cooperative Oncology Group (ECOG) measures level of functioning in terms of daily living abilities:

0-Fully active, able to carry on all pre-disease performance without restriction

1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work

Tumor Location  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Right Colon
3
  23.1%
Left Colon
10
  76.9%
KRAS/NRAS  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Wild Type (WT)
5
  38.5%
Mutated
6
  46.2%
Unknown
2
  15.4%
BRAF V600F  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
WT
11
  84.6%
Mutated
0
   0.0%
Unknown
2
  15.4%
Number of Metastatic Sites  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
1
8
  61.5%
2
5
  38.5%
1.Primary Outcome
Title Number of Adverse Events
Hide Description Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: events
Grade 1 250
Grade 2 119
Grade 3 24
Grade 4 0
2.Primary Outcome
Title Percent Change in Tumor Size
Hide Description Percent change in tumor size after cycle 6. Each cycle is 21 days.
Time Frame end of Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: Percent change
-43.0
(-49.8 to -1.3)
3.Secondary Outcome
Title Response Rate RECIST Criteria
Hide Description

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.

Time Frame end of Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
PR
8
  61.5%
SD
1
   7.7%
PD
2
  15.4%
Not evaluable
2
  15.4%
4.Secondary Outcome
Title Number of Participants With an Overall Response Rate (ORR)
Hide Description Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period
Time Frame up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  46.2%
5.Secondary Outcome
Title Best Overall Response Rate RECIST Criteria
Hide Description

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.

Time Frame up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
PR
6
  46.2%
SD
3
  23.1%
PD
2
  15.4%
Not evaluable
2
  15.4%
6.Secondary Outcome
Title Number of Participants With Best Overall Response Rate (ORR)
Hide Description 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.
Time Frame up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
8
  61.5%
7.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: months
11.5
(4.9 to 21.7)
8.Secondary Outcome
Title Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months
Hide Description

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.

Time Frame 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6 months
69
(48 to 99)
12 months
38
(19 to 76)
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival - Number of months still living since baseline
Time Frame up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genistein
Hide Arm/Group Description:
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: months
36.5
(29.5 to 50)
Time Frame 6 months
Adverse Event Reporting Description AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
 
Arm/Group Title Genistein Genistein and Chemotherapy
Hide Arm/Group Description Genistein 60mg/day orally for 4 days before chemotherapy. Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to chemotherapy.
All-Cause Mortality
Genistein Genistein and Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Genistein Genistein and Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Genistein Genistein and Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      13/13 (100.00%)    
Blood and lymphatic system disorders     
Bleeding   1/13 (7.69%)  1 6/13 (46.15%)  12
Neutropenia   0/13 (0.00%)  0 1/13 (7.69%)  1
Thromboembolism   0/13 (0.00%)  0 1/13 (7.69%)  1
Cardiac disorders     
Hypertension   1/13 (7.69%)  2 12/13 (92.31%)  88
Gastrointestinal disorders     
Diarrhea   0/13 (0.00%)  0 6/13 (46.15%)  23
Nausea   2/13 (15.38%)  10 8/13 (61.54%)  27
Vomiting   0/13 (0.00%)  0 2/13 (15.38%)  9
Intestinal Obstruction   0/13 (0.00%)  0 1/13 (7.69%)  2
Abdominal Pain   0/13 (0.00%)  1/13 (7.69%) 
Anorexia   0/13 (0.00%)  8/13 (61.54%) 
Constipation   1/13 (7.69%)  2/13 (15.38%) 
GERD  [1]  0/13 (0.00%)  8/13 (61.54%) 
General disorders     
Fatigue   2/13 (15.38%)  6 11/13 (84.62%)  55
Hot Flashes   2/13 (15.38%)  8 1/13 (7.69%)  1
Mucositis   0/13 (0.00%)  0 5/13 (38.46%)  11
Infections and infestations     
Fever   0/13 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Back Pain   1/13 (7.69%)  8/13 (61.54%) 
Nervous system disorders     
Cold Sensitivity   0/13 (0.00%)  0 12/13 (92.31%)  55
Headache   4/13 (30.77%)  11 1/13 (7.69%)  1
Neuropathy   2/13 (15.38%)  2 7/13 (53.85%)  34
Renal and urinary disorders     
Acute Kidney Injury   0/13 (0.00%)  8/13 (61.54%) 
Skin and subcutaneous tissue disorders     
Rash   2/13 (15.38%)  4 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Gastroesophageal reflux disease
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sofya Pintova
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-824-8461
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, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01985763     History of Changes
Other Study ID Numbers: GCO 13-1697
First Submitted: November 9, 2013
First Posted: November 15, 2013
Results First Submitted: March 26, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019