Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Accelerated Community Oncology Research Network
Study ID
NCT00611468
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Solid Tumor

Eligibility Criteria

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

Interventions

  • Topotecan — DRUG
    All subjects receive treatment with intravenous topotecan and oral erlotinib.
  • Erlotinib — DRUG
    All subjects receive treatment with intravenous topotecan and oral erlotinib.

Study Details

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Key Dates

First listed
Feb 11, 2008
Start date
Jun 30, 2006
Status verified
Aug 2011
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: Intravenous Topotecan and Oral Erlotinib
    All subjects receive treatment with intravenous topotecan and oral erlotinib.

Primary Outcome Measure

Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib [ Time Frame: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21). ]

Locations (1)

FacilityCityStateZIPSite coordinators
The West ClinicMemphisTennessee38120-

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By research site
The West Clinic· Memphis, TN

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