Overview

S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Lenograstim
Paclitaxel
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven, previously untreated
extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR
Previously treated with radiotherapy and/or surgery Measurable or evaluable disease outside
the area of prior surgical resection or a new lesion must be present

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least
3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times
upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no
greater than ULN Creatinine clearance at least 50 mL/min 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 any stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC
Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See
Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and
recovered