Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)|
- Length of survival [ Designated as safety issue: No ]
- Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire [ Designated as safety issue: No ]
- Treatment response as measured by RECIST criteria [ Designated as safety issue: No ]
- Dose intensity of chemotherapy [ Designated as safety issue: No ]
- Ratio of treatment courses given as in-patient versus out-patient [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Treatment cost [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
- Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer.
- Compare symptom control and quality of life of patients treated with these regimens.
- Compare response in patients treated with these regimens.
- Compare the dose intensity of these regimens in these patients.
- Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients.
- Compare the intensity and number and duration of toxic episodes in patients treated with these regimens.
- Compare cost and cost-effectiveness of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
- Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in arm I) IV over 1 hour on day 1.
- Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1.
In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.
Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.
After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112710
|Institute of Clinical Research - Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Birmingham Heartlands Hospital|
|Birmingham, England, United Kingdom, B9 5SS|
|Study Chair:||Hugh Jarrett||Institute of Clinical Research - Birmingham|