Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
- Registration Number
- NCT00905983
- Lead Sponsor
- Hospital Arnau de Vilanova
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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Histologically or cytologically confirmed diagnosis of advanced NSCLC.
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Stage III with pleural effusion and stage IV.
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Patients are 70 years old.
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Patients with 1 > ECOG PS =1.
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Patients must have at least one measurable lesion, no previously irradiated.
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Life expectancy of at least 12 weeks.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine and Docetaxel Gemcitabine and Docetaxel Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
- Primary Outcome Measures
Name Time Method Overall response rate = sum of complete and partial tumour responses divided by the number of included patients 2 & 4 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (11)
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital General de Elda
🇪🇸Elda, Alicante, Spain
Hospital Clínica de Benidorm
🇪🇸Benidorm, Alicante, Spain
Hospital Althaia, Xarxa Asistencial de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Provincial de Castellón
🇪🇸Castellón de la Plana, Castellón, Spain