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A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer


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

Docetaxel Docetaxel + Gemcitabine

For ever 2 patients treated, 1 will receive treatment A (docetaxel) and 1 will receive
treatment B (Docetaxel + Gemcitabine). 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:

- Biopsy-proven non-small cell lung cancer

- No previous chemotherapy.

- Age > 65 years

- Age < 65 years requires significant assistance to perform activities of daily

- Stage IV disease or stage IIIB disease

- Ability to perform activities of daily living with minimal assistance

- Measurable or evaluable disease

- Adequate bone marrow, liver and kidney

- All patients must sign written informed consent prior to study entry.

Exclusion Criteria:

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

- Brain metastases

- Meningeal metastases

- Other uncontrolled malignancies

- History of invasive cancer during the last 5 years

- Moderate to severe peripheral neuropathy

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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

median survival

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 52

NCT ID:

NCT00193323

Start Date:

August 2001

Completion Date:

January 2009

Related Keywords:

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

Name

Location

Tennessee Oncology, PLLCClarksville, Tennessee  37043