500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in
treating patients who have advanced non-small cell lung cancer.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed, newly diagnosed, advanced primary non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified), designated as 1 of the following stages: - Selected stage IIIB (excluding Pancoast tumors) - T4 lesion due to malignant pleural effusion OR - Multiple lesions in a single lobe containing a T3 or T4 primary - Stage IV (any T, any N, M1) - Recurrent disease after prior surgery and/or radiotherapy - Measurable or evaluable disease outside of prior radiation port - No bronchoalveolar carcinoma - No brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003) - Zubrod 2 (for age 18 and over) Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN OR - Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN Renal: - Not specified Other: - No prior severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80 - No grade 2 or greater sensory neuropathy - 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 - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior or concurrent biologic therapy for NSCLC - No concurrent filgrastim (G-CSF) Chemotherapy: - No prior systemic chemotherapy for NSCLC Endocrine therapy: - No prior or concurrent hormonal therapy for NSCLC Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e., painful bony lesions) allowed - No other concurrent radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior thoracic or other major surgery and recovered
Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00026156
Not Accepting Healthy Volunteers