Status:
UNKNOWN
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
Hospital Arnau de Vilanova
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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) stag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00905983
Start Date
October 1 2007
End Date
September 1 2011
Last Update
May 21 2009
Active Locations (11)
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1
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 3804
2
Hospital San Juan de Alicante
Alicante, Alicante, Spain, 03550
3
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain, 03501
4
Hospital General de Elda
Elda, Alicante, Spain, 03600