GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00878163
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Vismodegib — DRUG
    Given PO

Study Details

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.

Key Dates

First listed
Apr 8, 2009
Start date
Mar 31, 2009
Status verified
Mar 2026
Primary completion
Jan 22, 2013
Completion
Mar 6, 2027

Study Design

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

Arms

  • Experimental: Treatment (vismodegib, erlotinib hydrochloride, gemcitabine)
    Patients receive Hedgehog antagonist GDC-0449 PO QD and erlotinib hydrochloride PO QD on days 1-28. Some patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of erlotinib hydrochloride defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLOrlando Health Cancer Institute· Orlando, FLMayo Clinic in Rochester· Rochester, MN

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