Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas stage III pancreatic cancer stage IV pancreatic cancer recurrent pancreatic cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

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.

Arms:
arm 1: 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

Interventions: intervention 1: genistein intervention 2: erlotinib hydrochloride intervention 3: gemcitabine hydrochloride
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: