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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Torun, , 87-100 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung (NSCLC) Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00735904
Pfizer
Completed
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

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