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

A Multicenter, Randomized Trial for Stage IIIB or IV NSCLC Comparing Weekly Taxol(Paclitaxel) and Carboplatin(Paraplatin) Regimen Versus Standard Taxol and Carboplatin Administered Every Three Weeks, Followed by Weekly Taxol.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035152

Enrollment

444

Registered

2002-05-03

Start date

2000-06-30

Completion date

2004-12-31

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

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.

Interventions

DRUGPaclitaxel and carboplatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026