Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation
Status:
Terminated
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
It is a single-arm, open label clinical trial. Patients affected by relapsed or refractory
small-cell lung cancer patients with MGMT promoter methylation are included in this study;
they will be treated with oral Temozolomide 200 mg/m2 die for 5 consecutive days every 28
days. Treatment will be continued until tumor progression, intolerable toxicity or patient
refusal.
A Minimax Simon 2-stage design will be used. - First stage: 9 patients If 1 or less responses
will be observed, the trial will be ended.- Second stage: other 10 patients (for a total of
19 subjects enrolled) If 5 or less responses will be observed in 19 patients, the treatment
will not be considered active, while if 6 or more responses will be observed, the treatment
will be considered sufficiently active to warrant further testing. Since the rate of
methylation ranges from 20 to 48% the number of patients to be screened should be between 40
and 95.
The primary objective is to determine the overall response rate [ORR = CR + PR]; the
secondary objectives are to determine the time to Progression (TTP), the overall Survival
(OS), the toxicity and the correlation between response Rate (RR) and the level of MGMT
promoter methylation and/or base excision repair (BER) genes alterations.
Phase:
Phase 2
Details
Lead Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori