Status:
COMPLETED
MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbin...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00401492
Start Date
June 1 2002
End Date
April 1 2007
Last Update
July 13 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.