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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00735904
• Date of registration: 13/08/2008
• Primary sponsor: Pfizer
• Public title: Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
• Scientific title: Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
• Date of first enrolment: December 2008
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00735904
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Poland, Romania, South Africa, Ukraine

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung (NSCLC)

Intervention(s)

Drug: AG-013736

Drug: cisplatin

Drug: gemcitabine

Primary Outcome(s)

Objective Response Rate [Time Frame: 2.5 years]

Secondary Outcome(s)

Duration of Response [Time Frame: 2.5 years]

Overall Safety Profile [Time Frame: 2.5 years]

Overall Survival [Time Frame: 2.5 years]

Progression-Free Survival [Time Frame: 2.5 years]

Secondary ID(s)

A4061038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors