Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00376948
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Novasoy®, Gemcitabine & Erlotinib erlotinib hydrochloride 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 Novasoy®, Gemcitabine & Erlotinib gemcitabine hydrochloride 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 Novasoy®, Gemcitabine & Erlotinib genistein 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
- Primary Outcome Measures
Name Time Method Patients Alive at 6 months Median Overall Survival Estimate up to 17 months
- Secondary Outcome Measures
Name Time Method Grade 3 or Higher Toxicity Evaluation First day of each cycle 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
Response Duration Every 8 weeks 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.
pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation At start of study Tumor tissue collected from paraffin
Overall Objective Response Rate (Complete and Partial Response) Every 8 weeks Imaging tests (CT scan, CXR \[Chest X-Ray\], MRI or imaging studies as clinically indicated
Time to Treatment Failure Every 8 weeks 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 Every 8 weeks 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.
Trial Locations
- Locations (2)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States