NCT00030433
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
PHASE2
COMPLETED
NCT00030433
INTERVENTIONAL
Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
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.
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
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: gemcitabine hydrochloride
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: irinotecan hydrochloride
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network