NCT00263016TerminatedPhase 2
A Phase II Pilot Study of Combination of Irinotecan and Cisplatin in Docetaxel/Cisplatin-Responsive Advanced Non-Small Cell Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sanofi
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Tumour response rate
Study Overview
Brief Summary
Primary Objective:
- To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3 courses of docetaxel/cisplatin.
Secondary Objectives :
- To compare the time to progression after chemotherapy treatment between the IC and DC arms of treatment.
- To compare the toxicity profile of the IC and DC arms of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically proven non-small cell lung carcinoma at first diagnosis.
- •Stage IIIB or IV disease.
- •Tumour considered unresectable.
- •Performance status Karnofsky index > 60% or WHO performance status < or =
- •Previous therapy
- •Chemotherapy: None.
- •Previous radiation therapy: prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.
- •Laboratory requirements:
- •Hematology:
- •Neutrophils ≥ 2.0 10^9/l,
- •Platelets ≥ 100 10^9/l,
- •Hemoglobin ≥ 10 g/dl.
- •Hepatic function:Total bilirubin < 1 Upper Normal Limit (UNL), AST (SGOT) and ALT (SGPT) < 2.5 UNL,Alkaline phosphatase < 5 UNL ; except in presence of only bone metastasis and in absence of any liver disorders. Patients with AST and/or ALT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
- •Renal function: Creatinine < 140 µmol/l (1.6 mg/dl) ; if limit values, the calculated creatinine clearance should be > 60 ml/min.
Exclusion Criteria
- •Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.
- •Known clinical brain or leptomeningeal involvement.
- •Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by National Cancer Institute criteria.
- •Other serious illness or medical condition:
- •Congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias.
- •History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- •Active uncontrolled infection.
- •Peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids.
- •Past or current history of neoplasm other than non-small cell lung cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix.
- •Concurrent treatment with prednisone (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or unless chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent).
- •Definite contraindications for the use of corticosteroids.
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
- •Concurrent treatment with any other anti-cancer therapy.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Outcomes
Primary Outcomes
Tumour response rate
Survival at 1 year
Secondary Outcomes
- Time to progression
Investigators
Study Sites (1)
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