Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven locally advanced or metastatic non-small cell
lung cancer that is not amenable to curative surgery or radiotherapy
- No known CNS metastases
- No concurrent cord compression or superior vena cava syndrome requiring immediate
radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 40-70%
Life expectancy:
- At least 4 weeks
Hematopoietic:
- WBC at least 3,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10.0 g/dL
Hepatic:
- Bilirubin no greater than 3 times normal
- ALT and AST no greater than 3 times normal (5 times normal if liver metastasis
present)
Renal:
- Creatinine no greater than 1.5 times normal
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 3 months
after study
- No active infection
- No other concurrent serious, systemic disorder that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No other concurrent systemic chemotherapy
Endocrine therapy:
- Concurrent steroids allowed
Radiotherapy:
- See Disease Characteristics
- Concurrent palliative radiotherapy allowed
- No concurrent curative radiotherapy
Surgery:
- See Disease Characteristics
- Concurrent palliative surgery allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Nick Thatcher, PhD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000068683
NCT ID:
NCT00022009
Start Date:
July 2001
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell 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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