Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
This trial is active, not recruiting.
|Condition||carcinoma, non-small-cell lung|
|Treatment||gemcitabine and docetaxel|
|Sponsor||Hospital Arnau de Vilanova|
|Start date||October 2007|
|End date||September 2009|
|Trial size||48 participants|
|Trial identifier||NCT00905983, CPNM-ANC-07|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Alcoy, Spain||Hospital Virgen de los Lirios||no longer recruiting|
|Benidorm, Spain||Hospital Clínica de Benidorm||no longer recruiting|
|Elda, Spain||Hospital General de Elda||no longer recruiting|
|Manresa, Spain||Hospital Althaia, Xarxa Asistencial de Manresa||no longer recruiting|
|Castellón de la Plana, Spain||Hospital Provincial de Castellón||no longer recruiting|
|Sagunto, Spain||Hospital de Sagunto||no longer recruiting|
|Alicante, Spain||Hospital San Juan de Alicante||no longer recruiting|
|Valencia, Spain||Instituto Valenciano de Oncología||no longer recruiting|
|Valencia, Spain||Hospital Arnau de Vilanova||no longer recruiting|
|Valencia, Spain||Hospital Universitario La Fe||no longer recruiting|
|Valencia, Spain||Hospital Universitario Dr. Peset||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
time frame: 2 & 4 months
time frame: time from study entry to death from any cause
time frame: biweekly
Duration of response
time frame: time from first response (CR or PR) to tumor progression
Time to progression
time frame: time from study entry to observed tumor progression or death due to progression disease
Measurement of quality of life
time frame: 28 days
Male or female participants at least 70 years old.
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.
|Official title||Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.|
|Principal investigator||Alfredo Sánchez, Doctor|
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