Trial Outcomes & Findings for Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (NCT NCT00376948)
NCT ID: NCT00376948
Last Updated: 2021-03-01
Results Overview
COMPLETED
PHASE2
20 participants
at 6 months
2021-03-01
Participant Flow
Participant milestones
| Measure |
Novasoy®, Gemcitabine & Erlotinib
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 Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 Participants
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
|
|---|---|
|
Age, Continuous
|
58.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at 6 monthsOutcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 Participants
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
|
|---|---|
|
Patients Alive
|
10 participants
|
PRIMARY outcome
Timeframe: up to 17 monthsOutcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 Participants
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
|
|---|---|
|
Median Overall Survival Estimate
|
6.3 months
Interval 4.6 to 12.6
|
SECONDARY outcome
Timeframe: Every 8 weeksImaging tests (CT scan, CXR \[Chest X-Ray\], MRI or imaging studies as clinically indicated
Outcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=18 Participants
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 Objective Response Rate (Complete and Partial Response)
|
0.056 proportion of patients
Interval 0.012 to 0.215
|
SECONDARY outcome
Timeframe: Every 8 weeksImaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters.
Outcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=1 Participants
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
|
|---|---|
|
Response Duration
|
73 days
|
SECONDARY outcome
Timeframe: Every 8 weeksImaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.
Outcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=17 Participants
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
|
|---|---|
|
Time to Treatment Failure
|
2.04 months
Interval 1.74 to 3.48
|
SECONDARY outcome
Timeframe: Every 8 weeksImaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.
Outcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=19 Participants
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
|
|---|---|
|
Time to Progression
|
2.07 moths
Interval 2.04 to 8.34
|
SECONDARY outcome
Timeframe: First day of each cycleToxicity 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
Outcome measures
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 Participants
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
|
|---|---|
|
Grade 3 or Higher Toxicity Evaluation
stomach mucostis
|
1 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
diarrhea
|
3 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
fatigue
|
5 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
infection
|
1 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
nausea
|
7 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
neutrophil
|
4 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
pain
|
5 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
platelet
|
1 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
vomiting
|
4 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
wbc
|
2 Participants
|
|
Grade 3 or Higher Toxicity Evaluation
other toxicity
|
4 Participants
|
SECONDARY outcome
Timeframe: At start of studyPopulation: Data not collected
Tumor tissue collected from paraffin
Outcome measures
Outcome data not reported
Adverse Events
Novasoy®, Gemcitabine & Erlotinib
Serious adverse events
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • Number of events 3
|
|
General disorders
Fatigue
|
25.0%
5/20 • Number of events 5
|
|
Infections and infestations
Infection
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 7
|
|
Investigations
Neutrophil
|
20.0%
4/20 • Number of events 4
|
|
General disorders
Pain
|
25.0%
5/20 • Number of events 5
|
|
Investigations
Platelet
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Stomach, mucostis
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
White blood count (WBC)
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 4
|
Other adverse events
| Measure |
Novasoy®, Gemcitabine & Erlotinib
n=20 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • Number of events 11
|
|
General disorders
Fatigue
|
40.0%
8/20 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.0%
15/20 • Number of events 15
|
|
General disorders
Pain
|
35.0%
7/20 • Number of events 7
|
|
Investigations
Platelet
|
75.0%
15/20 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
75.0%
15/20 • Number of events 15
|
|
Gastrointestinal disorders
Stomach, mucositis
|
20.0%
4/20 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutrophil
|
35.0%
7/20 • Number of events 7
|
|
Blood and lymphatic system disorders
WBC (white blood count)
|
35.0%
7/20 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Number of events 6
|
Additional Information
Almhanna Khaldoun, M.D.
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place