Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT00376948
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Sep 15, 2006
Start date
May 31, 2005
Status verified
Feb 2021
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Patients Alive [ Time Frame: at 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-1379-
M. D. Anderson Cancer Center at University of TexasHoustonTexas77030-4009-

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