Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Study Overview
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Brief Summary
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There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent. This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status. In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer. The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.

Official Title
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Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2

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 with ECOG PS 2. 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; 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. Prior radiotherapy for NSCLC. 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 study drugs. Pregnant or lactating women (women of childbearing potential must use adequate contraception). 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: 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

| 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 and 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, Small Cell, Lung Neoplasms, Docetaxel, Gemcitabine, ECOG 2