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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Treatments

Drug: cisplatin

Drug: AG-013736

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735904

A4061038

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.