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
- genistein — DIETARY_SUPPLEMENT
- erlotinib hydrochloride — DRUG
- gemcitabine hydrochloride — DRUG
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 & ErlotinibNovasoy® 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | - |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | - |
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