Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a sensitive relapse
- Conditions
- Patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a sensitive relapse (extensive or limited disease).MedDRA version: 9.1Level: LLTClassification code 10041067Term: Small cell lung cancer
- Registration Number
- EUCTR2006-002485-19-DE
- Lead Sponsor
- EORTC-European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
¨ Histologically proven small cell lung cancer
¨ Chemotherapy naïve or sensitive relapse (that is, off first line treatment > 3 months)
¨ Presence of measurable disease, as defined in the RECIST criteria (see chapter on Response evaluation).
¨ Extensive disease when chemotherapy naïve
¨ Age > 18 years
¨ WHO PS 0-2
¨ Life expectancy > 12 weeks
¨ Adequate organ function as defined by the following criteria:
- Absolute neutrophil count (ANC) = 1.5 x 109/L
- Platelets = 100 x 109/L
- Serum asparatate aminotransferase (AST; serum glutamate-oxalate transferase (SGOT)) and serum aminotransferase (ALT; serum glutamate-pyruvate transferase (SGPT)) = 2.5 x upperlimit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy.
- Total serum bilirubin = 1.5 x ULN
- Serum albumin = 3.0 g/dL
¨ For women: patient must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; they also must have a negative serum or urine pregnancy test performed within 28 days before registration and must not be lactating.
¨ For men: patient must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period.
¨ Written informed consent must be given according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
¨ Brain metastases (according to CT or MRI scan performed not earlier than one week prior to the start of treatment)
¨ Prior chemotherapy, radiation therapy, surgery or investigational agent within 4 weeks prior to study entry except for palliative radiotherapy to non-target lesions.
¨ Prior treatment with sunitinib (SU011248) or other receptor tyrosinekinase inhibitors
¨ Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should be off radiotherapy for at least 1 month and be off treatment with steroids
¨ Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within 6 months prior to starting study treatment
¨ NCI CTCAE grade 3 hemorrhage within 4 weeks before the start of the treatment
¨ Hypertension ( > 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents.
¨ Ongoing cardiac dysrhythmias of grade = 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females.
¨ Other severe acute or chronical medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
¨ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the therapeutic activity of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse.;Secondary Objective: To characterize the safety of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse (more than three<br>months off induction chemotherapy). For patients presenting with an objective response, the duration of response will be assessed.;Primary end point(s): The primary endpoint is the disease control rate 8 weeks after the start of treatment, i.e. the percent of patients with complete response, partial response, or stable disease at 8 weeks according to the RECIST criteria. Patients lost to follow up prior to 8 weeks are considered to be a treatment failure.
- Secondary Outcome Measures
Name Time Method