Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy.

PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.

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

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• Patients must voluntarily sign and date an informed consent before the initiation of any study procedures

• Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion

• Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC

• Patients must have at least one site of unidirectionally measurable disease

• Patients must be ≥ 3 weeks from a formal exploratory thoracotomy

• Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry

• Patients must be ≥ 18 years of age

• Women of childbearing potential must have a negative baseline serum pregnancy within 7 days prior to Week 1, Day 1 and must not be breast feeding.

• Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.

• Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:

• Absolute neutrophil count (ANC) > 1,500/mm3

• Hemoglobin > 9.0 gm/dL

• Creatinine < 1.5

• Platelets > 100,000/mm3

• Total bilirubin within normal limits (WNL)

• AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per chart on page 10 of the protocol.

• Calculated CrCl > 50 ml/min (via Cockroft-Gault formula).

• Forced expiratory volume in 1 second (FEV 1) > 800 ml

Exclusion Criteria:

• Known hypersensitivity to drugs formulated with polysorbate 80

• Peripheral neuropathy Grade ≥ 2.

• Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC

• Previous chemotherapy or radiation therapy

• Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder

• Pregnant or nursing women

• A greater than or equal to 10% weight loss over the past 3 months