Status:
COMPLETED
PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
Eligibility Criteria
Inclusion
- At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)
Exclusion
- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00174356
Start Date
December 1 2002
End Date
October 1 2005
Last Update
November 8 2006
Active Locations (7)
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1
Pfizer Investigational Site
Tampa, Florida, United States, 33612
2
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
3
Pfizer Investigational Site
Skokie, Illinois, United States, 60076
4
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202