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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.)

Official Title
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Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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