Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Study Overview
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Brief Summary
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Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.

Official Title
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Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Gemcitabine and Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced NSCLC. Stage III with pleural effusion and stage IV. Patients are 70 years old. Patients with 1 > ECOG PS =1. Patients must have at least one measurable lesion, no previously irradiated. Life expectancy of at least 12 weeks. Adequate organ function according to the following criteria: Bone marrow: ANC >= 2.0x10(9)cells/L; Platelet count >= 100x10(9)cells/L; Leukocyte count >= 4000x10(6)/L; Hemoglobin >= 10 g/dL. Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN;AST and ALT <= 1.5 x ULN. Renal function: serum creatinine <= 2mg/dL. Exclusion Criteria: Prior systemic chemotherapy for advanced disease. Patients with symptomatic brain metastases. No measurable bone metastases or malignant pleural effusion as only measurable lesion. History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years. History of hypersensitivity reaction to study drugs. Concurrent treatment with other experimental drugs. Current peripheral neuropathy NCI grade 2. Participation in clinical trials within 30 days of study entry. Major surgery, open biopsy or traumatic lesion 28 days before to study start.

Ages Eligible for Study
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Minimum Age: 70 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: Gemcitabine and Docetaxel<br>Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14. | Drug: Gemcitabine and Docetaxel<br>* Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate = sum of complete and partial tumour responses divided by the number of included patients |  | 2 & 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | time from study entry to death from any cause | 
| Toxicity |  | biweekly | 
| Duration of response |  | time from first response (CR or PR) to tumor progression | 
| Time to progression |  | time from study entry to observed tumor progression or death due to progression disease | 
| Measurement of quality of life |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell, Elderly patients, Docetaxel, Gemcitabine