Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
genistein
erlotinib hydrochloride
gemcitabine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
- Locally advanced or metastatic disease by radiological evidence
- Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies
- No endocrine tumor or lymphoma of the pancreas
- No history of CNS (central nervous system) metastases
PATIENT CHARACTERISTICS:
- SWOG (Southwest Oncology Group) performance status 0-1
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Bilirubin < 2.0 mg/dL
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal
- Creatinine < 1.5 mg/dL
- Albumin > 2.5 g/dL
- INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No condition that would limit the ability to receive oral medications
- No requirement for a gastrostomy tube for the administration of drugs
- No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study
- No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
- No allergy to any study drug
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago
- No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents
- No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy
- No other concurrent investigational agents
- No other concurrent antitumor therapy
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
- M. D. Anderson Cancer Center at University of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Novasoy®, Gemcitabine & Erlotinib
Arm 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
Outcomes
Primary Outcome Measures
Patients Alive
Median Overall Survival Estimate
Secondary Outcome Measures
Overall Objective Response Rate (Complete and Partial Response)
Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated
Response Duration
Imaging 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.
Time to Treatment Failure
Imaging 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.
Time to Progression
Imaging 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.
Grade 3 or Higher Toxicity Evaluation
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
pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation
Tumor tissue collected from paraffin
Full Information
NCT ID
NCT00376948
First Posted
September 13, 2006
Last Updated
February 25, 2021
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00376948
Brief Title
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine and erlotinib works in treating patients with locally advanced or metastatic pancreatic cancer.
Detailed Description
OBJECTIVES:
Primary
Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride.
Secondary
Determine the frequency of objective tumor response rate in these patients.
Determine the time to treatment failure in these patients.
Determine the effect of baseline expression of pAKT and activation of NF-kappaB on survival of patients treated with this regimen.
Determine the overall time to disease progression in these patients.
Estimate the quantitative and qualitative toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral genistein twice daily on days -7 to 28 in course 1 and on days 1-28 in all other courses. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novasoy®, Gemcitabine & Erlotinib
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
genistein
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Patients Alive
Time Frame
at 6 months
Title
Median Overall Survival Estimate
Time Frame
up to 17 months
Secondary Outcome Measure Information:
Title
Overall Objective Response Rate (Complete and Partial Response)
Description
Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated
Time Frame
Every 8 weeks
Title
Response Duration
Description
Imaging 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.
Time Frame
Every 8 weeks
Title
Time to Treatment Failure
Description
Imaging 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.
Time Frame
Every 8 weeks
Title
Time to Progression
Description
Imaging 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.
Time Frame
Every 8 weeks
Title
Grade 3 or Higher Toxicity Evaluation
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
Title
pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation
Description
Tumor tissue collected from paraffin
Time Frame
At start of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
Locally advanced or metastatic disease by radiological evidence
Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies
No endocrine tumor or lymphoma of the pancreas
No history of CNS (central nervous system) metastases
PATIENT CHARACTERISTICS:
SWOG (Southwest Oncology Group) performance status 0-1
Life expectancy ≥ 12 weeks
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Bilirubin < 2.0 mg/dL
AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal
Creatinine < 1.5 mg/dL
Albumin > 2.5 g/dL
INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
No condition that would limit the ability to receive oral medications
No requirement for a gastrostomy tube for the administration of drugs
No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study
No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
No allergy to any study drug
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for metastatic disease
Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago
No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents
No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy
No other concurrent investigational agents
No other concurrent antitumor therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaldoun Almhanna, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fazlul H. Sarkar, PhD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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