Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors

Sponsor
University Health Network, Toronto
Study ID
NCT00126620
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

Study Details

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and erlotinib in treating patients with metastatic or unresectable solid tumors.

Key Dates

First listed
Aug 4, 2005
Start date
Sep 30, 2005
Status verified
Jul 2015
Primary completion
May 31, 2011

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OSI-774 erlotinib) and Bay 43-9006 (Sorafenib)
    Sorafenib administered alone for a 1-week run-in period, and then both drugs e given together continuously, with every 28 days considered as a cycle. Three dose levels assessed.

Primary Outcome Measure

Maximum tolerated dose and recommended phase II dose [ Time Frame: 28 days ]

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