Overview

Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Axitinib
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.