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Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00376948
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : August 26, 2014
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Dietary Supplement: genistein
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Novasoy®, Gemcitabine & Erlotinib
Hide Arm/Group Description

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28

genistein

erlotinib hydrochloride

gemcitabine hydrochloride

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Novasoy®, Gemcitabine & Erlotinib
Hide Arm/Group Description

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28

genistein

erlotinib hydrochloride

gemcitabine hydrochloride

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
58.5
(39 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Patients Alive
Hide Description [Not Specified]
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Novasoy®, Gemcitabine & Erlotinib
Hide Arm/Group Description:

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28

genistein

erlotinib hydrochloride

gemcitabine hydrochloride

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
10
2.Primary Outcome
Title Median Overall Survival Estimate
Hide Description [Not Specified]
Time Frame up to 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Novasoy®, Gemcitabine & Erlotinib
Hide Arm/Group Description:

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28

genistein

erlotinib hydrochloride

gemcitabine hydrochloride

Overall Number of Participants Analyzed 20
Median (90% Confidence Interval)
Unit of Measure: months
6.3
(4.6 to 12.6)
3.Secondary Outcome
Title Overall Objective Response Rate (Complete and Partial Response)
Hide Description Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated
Time Frame Every 8 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Response Duration, Time to Treatment Failure, and Time to Progression
Hide Description Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated
Time Frame Every 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Toxicity
Hide Description Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9
Time Frame First day of each cycle
Outcome Measure Data Not Reported
6.Secondary Outcome
Title pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation
Hide Description Tumor tissue collected from paraffin
Time Frame At start of study
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Novasoy®, Gemcitabine & Erlotinib
Hide Arm/Group Description

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28

genistein

erlotinib hydrochloride

gemcitabine hydrochloride

All-Cause Mortality
Novasoy®, Gemcitabine & Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Novasoy®, Gemcitabine & Erlotinib
Affected / at Risk (%) # Events
Total   14/20 (70.00%)    
Blood and lymphatic system disorders   
White blood count (WBC)  1  2/20 (10.00%)  2
Gastrointestinal disorders   
Diarrhea  1  3/20 (15.00%)  3
Nausea  1  7/20 (35.00%)  7
Stomach, mucostis  1  1/20 (5.00%)  1
Vomiting  1  4/20 (20.00%)  4
General disorders   
Fatigue  1  5/20 (25.00%)  5
Pain  1  5/20 (25.00%)  5
Infections and infestations   
Infection  1  1/20 (5.00%)  1
Investigations   
Neutrophil  1  4/20 (20.00%)  4
Platelet  1  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Novasoy®, Gemcitabine & Erlotinib
Affected / at Risk (%) # Events
Total   15/20 (75.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  15/20 (75.00%)  15
Neutrophil  1  7/20 (35.00%)  7
WBC (white blood count)  1  7/20 (35.00%)  7
Gastrointestinal disorders   
Diarrhea  1  11/20 (55.00%)  11
Stomach, mucositis  1  4/20 (20.00%)  4
Vomiting  1  4/20 (20.00%)  4
Nausea  1  6/20 (30.00%)  6
General disorders   
Fatigue  1  8/20 (40.00%)  8
Pain  1  7/20 (35.00%)  7
Investigations   
Platelet  1  15/20 (75.00%)  15
Skin and subcutaneous tissue disorders   
Skin rash  1  15/20 (75.00%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
This study was stopped early due to the lack of efficacy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Almhanna Khaldoun, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8746
EMail: almhanna@karmanos.org
Layout table for additonal information
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00376948     History of Changes
Other Study ID Numbers: CDR0000495776
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2005-006
WSU-025806MP4F
First Submitted: September 13, 2006
First Posted: September 15, 2006
Results First Submitted: August 8, 2014
Results First Posted: August 26, 2014
Last Update Posted: December 4, 2017