Small Cell Lung Cancer MedDRA version: 17.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: TEMOZOLOMIDE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: temozolomide
Other descriptive name: TEMOZOLOMIDE
Con
Sponsors
IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed SCLC with MGMT methylation. 2. Patient previously treated by one or two chemotherapy lines. 3. Age = 75 and Eastern Cooperative Oncology Group (ECOG) Performance Status =2. 4. Patients must have measurable disease, defined as at least one lesion than can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20mm with conventional techniques or as >10mm with spiral CT scan. 5. Patient with controlled brain metastases are eligible. 6. Patient previously treated with chest and/or brain RT are eligible. 7. Life expectancy >3 months. 8. Patient must have normal organ and marrow function as defined below: - leukocytes >3,000/µL - absolute neutrophil count >1,000/µL - platelets >100,000/µL - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed SCLC without MGMT methylation. 2. Patients who have received three or more previous chemotherapy lines for small cell lung cancer or radiotherapy on target lesions. 3. Symptomatic uncontrolled CNS metastasis. 4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 5. Presence of infection. 6. History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function. 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or other agents used in the study. 8. Presence of medical problems of sufficient severity to prevent full compliance with the study. 9. Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • TTP • OS • Toxicity • Correlation between Response Rate (RR) and level of MGMT promoter methylation and/or BER genes alterations. ;Primary end point(s): The primary endpoint is the overall response rate [ORR = CR + PR] according to RECIST 1.1 criteria. ;Timepoint(s) of evaluation of this end point: 3 YEARS;Main Objective: Overall response rate [ORR = CR + PR] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are Time to Progression (TTP), Toxicity, Overall Survival (OS), the correlation between Response Rate (RR) and level of MGMT promoter methylation and/or BER genes alterations.;Timepoint(s) of evaluation of this end point: 3 YEARS | — |
Countries
Italy
Contacts
Public ContactDATA MANAGER
IRCCS IRST
Outcome results
None listed