s0027: vinorelbine followed by docetaxel in treating patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

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.

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.)

Eligibility 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

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