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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


18 and older



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

Gender: Both
Steward Physician(s)
  • Frank Dunphy, MD
Trial Interventions
  • filgrastim
  • carboplatin
  • paclitaxel
  • topotecan hydrochloride
Physician Researcher

Investigator Name:

  • Frank Dunphy, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00004137
Volunteers:  Not Accepting Healthy Volunteers

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