Know Cancer

or
forgot password

Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer


Upon determination of eligibility, patients will be randomly assigned to one of two
treatment arms:

- Paclitaxel + Carboplatin + Gemcitabine

- Gemcitabine + Vinorelbine

For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin +
Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not
blinded so both the patient and the doctor will know which treatment has been assigned.


Inclusion Criteria:



To be included in this study, you must meet the following criteria:

- Non-small cell bronchogenic carcinoma

- Newly diagnosed unresectable stage IIIB or stage IV disease

- Patients with stage IIIB disease should be ineligible for combined therapy

- Patients must have measurable lesion definable by X-ray or CT scan.

- No prior antineoplastic chemotherapy for lung cancer prior to study entry

- Age > 18 years

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, liver and kidney function

- Written informed consent must be obtained prior to study entry

- Patients must be available for treatment and followup.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Female patient pregnant or lactating

- History of heart disease

- Serious active infection at the time of treatment

- Other serious underlying medical condition

- Brain metastasis

- Patients without measurable disease

- Uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dL

- Dementia or significantly altered mental status

- Significant peripheral neuropathy by history or physical examination.

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival.

Principal Investigator

Anthony Greco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 54

NCT ID:

NCT00193362

Start Date:

June 2004

Completion Date:

September 2007

Related Keywords:

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

Name

Location