NCT00004137

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

Official Title:

Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer

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.

Eligibility

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

Disease(s) and\or Condition(s)

Lung Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: carboplatin
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: paclitaxel
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: topotecan hydrochloride
    • Description:
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network