Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer

The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Inclusion Criteria:

• Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
• ECOG status 0-1
• >14 and <56 days since resection

Exclusion Criteria:

• Prior chemotherapy and/or radiation therapy for lung cancer
• Peripheral neuropathy > grade 1
• Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Medical condition that will not permit treatment or follow up according to the protocol
• Prior treatment with docetaxel or carboplatin
• Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
• Treatment with other investigational anti-cancer drugs within 30 days of registration
• Pregnant or nursing women
• HIV-positive patients