Lung Cancer
Conditions
Keywords
recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
Brief summary
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.
Detailed description
OBJECTIVES: * Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2, when treated with sequential vinorelbine and docetaxel. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.) * Determine the objective tumor response rates, including confirmed and unconfirmed and complete and partial, in patients treated with this regimen. * Assess the dose delivered and the reported functional symptom status of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients. OUTLINE: This is a multicenter study. Patients are stratified according to age and performance status (age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2). (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.) Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Beginning 2 weeks after the last dose of vinorelbine, patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of courses 2-6, and at week 22. Patients are followed at week 22, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A minimum of 95 patients (55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2) will be accrued for this study within 12-18 months. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)
Interventions
DRUGdocetaxel
DRUGvinorelbine tartrate
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed