Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title: A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN01-24

Status Completed

Clinical Trial Summary

In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.

This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Clinical Trial Description

OUTLINE: This is a multi-center study.

• Cisplatin 50 mg/m2 d1, 8, 29, 36

• Etoposide 50 mg/m2/day d1-5, 29-33

• Radiation 5940 cGy (180 cGy/day)

Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles

or Observation Only

Performance Status: ECOG 0 or 1

Life Expectancy: Not specified

Hematopoietic:

• ANC > 1,500/mm3

• Platelet count > 100,000/mm3

• Hemoglobin > 8 g/dl. PRBC transfusions will be allowed to increase hemoglobin to >8 g/dl

Hepatic:

• Serum bilirubin < institutional upper limit of normal (ULN)

• AST < 2.5 X the upper limits of normal if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 X ULN if AST are < ULN

Renal:

• Serum creatinine of < 2 mg/dl or calculated creatinine clearance > 50 cc/min

Cardiovascular:

• No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication).

Pulmonary:

• Pre-registration FEV1 > 1 liters by spirometry within 42 days prior to study treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT00216125
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Completed
• Phase: Phase 3
• Start date: February 2002
• Completion date: March 2008