A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: sunitinib; Drug: carboplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113516

A6181057

Details and patient eligibility

About

The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven NSCLC
• Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
• No prior therapy for NSCLC
• Evidence of unidimensionally measurable disease

Exclusion criteria

• Previous treatment with systemic chemotherapy for lung cancer
• History of or known brain metastases
• NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
• Evidence of hemoptysis within 4 weeks of starting study treatment
• Serious acute or chronic illness or recent history of significant cardiac abnormality
• Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

1

Experimental group

Treatment:

Drug: paclitaxel

Drug: carboplatin

Drug: sunitinib