S0027: Vinorelbine Followed by Docetaxel in Treating Patients With 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.)

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