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)
18 Years
N/A
Both
Lung Cancer
Trial Information
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)
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting
1 of the following stage criteria:
- Stage IIIB disease* that is not suitable for radical radiotherapy
- Stage IV disease* NOTE: *Radiographically verified
- At least 1 measurable lesion by clinical examination or radiography
- No mixed histologies of small cell lung cancer and NSCLC
- No clinically apparent brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are
present)
- Alkaline phosphatase < 3 times ULN
- Bilirubin < 1.5 times ULN
Renal
- Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA
clearance)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able and willing to participate in the quality of life assessment
- No pre-existing neuropathy > grade 2
- No other malignancy that would preclude study treatment or study comparisons
- No evidence of severe or uncontrolled systemic disease, significant clinical
disorder, or laboratory finding that would preclude study participation
- No psychiatric disorder that would preclude study participation
- No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
- No other concurrent cytotoxic chemotherapy
Endocrine therapy
- No concurrent hormonal therapy except contraceptives or replacement steroids
Radiotherapy
- No prior radiotherapy
Surgery
- Recovered from prior surgery
- Prior surgical resection for NSCLC allowed
Other
- More than 12 weeks since prior investigational agents and recovered
- No other concurrent specific antitumor therapy
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Length of survival
Safety Issue:
No
Principal Investigator
Hugh Jarrett
Investigator Role:
Study Chair
Investigator Affiliation:
Institute of Clinical Research - Birmingham
Authority:
Unspecified
Study ID:
CDR0000429610
NCT ID:
NCT00112710
Start Date:
March 2005
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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