Status:
COMPLETED
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
Eligibility Criteria
Inclusion
- Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
- Candidate for primary treatment with cisplatin and gemcitabine
- Presence of measurable disease by RECIST
- Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
Exclusion
- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
- History of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- Untreated brain metastases.
- Need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), NSAID or other medications known to inhibit platelet function.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00735904
Start Date
December 1 2008
End Date
November 1 2011
Last Update
January 3 2013
Active Locations (10)
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1
Pfizer Investigational Site
Torun, Poland, 87-100
2
Pfizer Investigational Site
Wodzislaw Sl., Poland, 44-300
3
Pfizer Investigational Site
Cluj-Napoca, Cluj, Romania, 400015
4
Pfizer Investigational Site
Bucharest, Romania, 022328