Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

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

Details

• Lead Sponsor: Duke University
• Collaborator: Sanofi
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;

• IIIA: T1-3 N2 M0, T3 N1 M0

• IIIB: T4 N0-2 M0, T 1-4 N3 M0

• Measurable or evaluable disease

• Previously untreated with chemotherapy or radiotherapy for lung cancer;

• No brain metastases;

• No prior XRT

• Performance status 0-2

• ≥18 years of age

• Informed Consent

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelets ≥ 100 x 109/L

• Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)

• SGOT and SGPT ≤ 2.5 x ULN for the institution

• Creatinine ≤ 1.6 mg/dL

• Hemoglobin ≥ 8.0 g/dL

• Peripheral neuropathy ≤ grade 1

Exclusion Criteria:

• Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);

• Use of IV systemic antibiotics within 72 hours prior to chemotherapy;

• Known HIV infection

• Lithium or cytokines within 2 weeks prior of entry

• Additional concurrent investigational drugs

• History of myelodysplastic syndrome

• Pregnant, nursing or having unprotected sex

• Not available for follow-up assessment

• Unable to comply with protocol procedures

• Illnesses that may compromise ability to give informed consent.

• Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.