Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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.
Dietary Supplement: genistein
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer|
- Survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 6 months after off study ] [ Designated as safety issue: No ]
- Overall objective response rate (complete and partial response) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated
- Response duration, time to treatment failure, and time to progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated
- Toxicity [ Time Frame: First day of each cycle ] [ Designated as safety issue: Yes ]Toxicity evaluation using NCI-CTC v.3 criteria; CBC 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 and NF-kappaB activation [ Time Frame: At start of study ] [ Designated as safety issue: No ]Tumor tissue collected from paraffin
|Study Start Date:||May 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: 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
|Dietary Supplement: genistein Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride|
- Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376948
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Khaldoun Almhanna, MD||Barbara Ann Karmanos Cancer Institute|
|Principal Investigator:||Fazlul H. Sarkar, PhD||Barbara Ann Karmanos Cancer Institute|