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Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation

NCT02477813 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-11-13

No results posted yet for this study

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.

Conditions

  • Small Cell Lung Cancer Recurrent

Interventions

DRUG

Temozolomide

200 mg/m2 die for 5 consecutive days every 28 days. Treatment will be continued until tumor progression, intolerable toxicity or patient refusal

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Claudia Casanova, MD · Oncology Department, PO Ravenna, AUSL della Romagna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477813 on ClinicalTrials.gov