Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
70 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
The study design includes three parallel phase II studies, all with the same rules for
patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a
dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing
doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the
three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 & 8 of each
cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of
each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day
1 of each cycle, every 21 days, for a maximum of 6 cycles.
Inclusion Criteria:
- Histologic or cytologic diagnosis of NSCLC
- Stage IV or IIIB with pleural effusion or metastatic supraclavicular
lymphoadenopathy
- Age > o = 70 years.
- Written informed consent.
Exclusion Criteria:
- Performance status (ECOG) ³2
- Previous chemotherapy.
- Symptomatic brain metastases requiring synchronous radiotherapy
- Previous radiotherapy (completed less than 4 weeks before enrollment)
- Previous or synchronous malignant disease (except adequately treated non
melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last
five years before enrollment.
- Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
- Serum creatinine > 1.5 times the UNL.
- GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL
without hepatic metastases.
- GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with
hepatic metastases.
- Other concomitant diseases contraindicating the study treatments.
- Refusal of written informed consent.
- Follow-up impossible.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Principal Investigator
Cesare Gridelli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
San Giuseppe Moscati Hospital
Authority:
Italy: Ethics Committee
Study ID:
MILES-02
NCT ID:
NCT00401492
Start Date:
June 2002
Completion Date:
April 2007
Related Keywords:
- Non Small Cell Lung Cancer
- elderly
- chemotherapy
- quality of life
- ADL
- toxicity
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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