Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.

Detailed Description
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OBJECTIVES: I. Determine the response rate to carboplatin and paclitaxel in elderly patients with metastatic or recurrent unresectable non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine if the hypothesized lack of social support impacts the recruitment of elderly patients into clinical trials. IV. Determine if a previously validated tool of functional status in the elderly predicts treatment related toxicity superior to that predicted by the ECOG performance status in this patient population.

Official Title
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A Phase II Study of Carboplatin and Paclitaxel in Elderly Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative or significant palliative therapies available Measurable disease At least one lesion a minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS metastases PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3 years except adequately treated basal or squamous cell skin cancer or noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease except as radiosensitizer No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy except for CNS therapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery

Ages Eligible for Study
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Minimum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carboplatin + paclitaxel<br>Following completion of the Lubben Social Network Scale and Frailty Questionnaire, patients receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses. Patients with complete response receive 2 additional courses of therapy. Patients with partial response or stable disease may receive additional courses of therapy at investigator's discretion. Patients are followed every 3 months for 5 years or until disease progression. | Drug: carboplatin<br> <br> Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | Up to 5 years | 

 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, stage IV non-small cell lung cancer