Gemcitabine Plus Supportive Care in Treating Patients With Locally

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment.

PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

- Compare quality of life, in terms of the degree of symptom palliation and improvements in performance status, of patients with locally advanced or metastatic poor prognosis non-small cell lung cancer treated with 2 schedules of gemcitabine combined with best supportive care.

- Compare the toxicity of these regimens in these patients.

- Compare the overall survival of patients treated with these regimens.

- Compare the response rate in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes once a week for 3 weeks. Treatment continues every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 30 minutes once a week for 2 weeks. Treatment continues every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients on both arms also receive best supportive care. Additional courses of gemcitabine may be administered at the discretion of the investigator.

Quality of life is assessed at baseline and then after each course of chemotherapy.

Patients are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 174 patients (87 per treatment arm) will be accrued for this study. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00022009
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	July 2001

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms