S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

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