Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Aventis Pharmaceuticals
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

Histologically confirmed stage IIIA or IIIB NSCLC

• Patients must have measurable disease

• No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.

• Age>18 years

• Life expectancy >12 months

• ECOG performance status 0-1

• Normal organ and marrow function

• Medically fit for surgery at time of enrollment.

• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.

• Ability to understand and willingness to sign the consent form.

Exclusion Criteria:

• Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.

• Patients receiving any other investigational agents.

• Known metastatic disease (brain or any other site)

• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.

• Peripheral neuropathy >grade 1

• Uncontrolled concurrent illness

• Pregnant women

• Weight loss>10% in the past 3 months before diagnosis.

• Hyperglycemia - exclusion from PET analysis

• HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.