Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine and Docetaxel
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Hospital Arnau de Vilanova
- Enrollment
- 48
- Locations
- 11
- Primary Endpoint
- Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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 =
- •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
- •Participation in clinical trials within 30 days of study entry.
- •Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Arms & Interventions
Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Intervention: Gemcitabine and Docetaxel
Outcomes
Primary Outcomes
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time Frame: 2 & 4 months
Secondary Outcomes
- 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)