Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

Pfizer49 enrolled

Overview

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Non Small Cell Lung Cancer

Interventions

sunitinibDRUG

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)

docetaxelDRUG

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Advanced solid tumor malignancy ECOG 0 or 1 Exclusion Criteria: Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

Locations (5)

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities

Time frame: November 2007

Secondary Outcomes

Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.

Time frame: November 2007

Objective disease response

Time frame: November 2007

Data from ClinicalTrials.gov

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