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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Mann
• Collaborator: Sanofi
• Treatments: Carboplatin; Docetaxel

Criteria

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