Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=343695&version=patient&protocolsearchid=1026401

Phase III Randomized Study of Gemcitabine and Carboplatin Followed By Immediate Versus Delayed Docetaxel in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Purpose:

Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.

Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Eligibility:

  • At least 19 years old
  • No previous chemotherapy for non-small cell lung cancer
  • A least 3 weeks since radiation therapy

Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements for this trial and the treatment or intervention, refer to the Health Professional version of the trial summary

Treatment/Intervention:

All patients will receive a 30- to 60-minute infusion of carboplatin on day 1. They will also receive a 30- to 60-minute infusion of gemcitabine on days 1 and 8. Treatment may be repeated every 3 weeks for up to four courses.

Patients will then be randomly assigned to one of two groups. Patients in group one will receive a 1-hour infusion of docetaxel every 3 weeks for up to six courses. Patients in group two will be observed until the first sign of disease progression. They will then receive a 1-hour infusion of docetaxel every 3 weeks for up to six courses.

Quality of life will be assessed periodically. Patients will be evaluated once a month for 3 months, every 2 months for 6 months, and every 3 months thereafter.

Important:

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Ohio

Cleveland
Ireland Cancer Center
Nathan Levitan, MD