Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer
Brief summary
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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan. * Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen. * Determine the overall toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.
Interventions
DRUGgemcitabine hydrochloride
DRUGirinotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) * Malignant pleural effusion constitutes extensive stage disease * Must have disease outside area of prior surgical resection or a new lesion must be present * Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy) * Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN Renal: * Not specified Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for SCLC Chemotherapy: * No prior systemic chemotherapy for SCLC Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy for SCLC except for brain metastases Surgery: * See Disease Characteristics * At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
Countries
United States
Outcome results
None listed