Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
RATIONALE: Drugs used in chemotherapy 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 if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.
PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)|
- Rate of hospitalization due to toxicity [ Designated as safety issue: Yes ]
- Need for hospitalization for chemotherapy administration [ Designated as safety issue: No ]
- Tumor response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Relief of tumor-related symptoms [ Designated as safety issue: No ]
- Effect on Karnofsky performance status [ Designated as safety issue: No ]
- Toxicity as measured by NCIC CTC v2.0 [ Designated as safety issue: Yes ]
|Study Start Date:||November 2002|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin.
- Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens.
- Compare the tumor response rate of patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the relief of tumor-related symptoms in patients treated with these regimens.
- Compare the effect on Karnofsky performance status in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 6 months and then every 3-4 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055965
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Nick Thatcher, PhD, FRCP||The Christie NHS Foundation Trust|