Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Paclitaxel and carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035152

BMS TAX/MEN.12

Details and patient eligibility

About

Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.

This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.

The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
• No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
• No previous irradiation to the only area of measurable disease.

Exclusion criteria

• Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
• Patients who have undergone surgery less than 3 weeks prior to enrollment.
• History of serious cardiac disease not adequately controlled.
• Patients with serious active infections or other serious underlying medical condition.
• Uncontrolled diabetes mellitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)