Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SWOG Cancer Research Network
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
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
Clareo Health | S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
