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

NCT02477813 | Terminated Phase 2

• 1 other identifier: IRST162.09
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR):

  The percentage of patients whose cancer achieve either a partial response or a complete response

  from randomization up to 3 years

Secondary Outcomes (2)

• Time to tumor progression (TTP)

  from randomization up to 36 months

• Overall survival time (OS):

  from randomization up to 36 months

Study Arms (1)

Temozolomide

EXPERIMENTAL

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

Drug: Temozolomide

Interventions

Temozolomide DRUG

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

Temozolomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed SCLC with MGMT methylation.
• Patient previously treated by one or two chemotherapy lines.
• Age ≤ 75 and Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
• 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.
• Patient with controlled brain metastases are eligible.
• Patient previously treated with chest and/or brain RT are eligible.
• Life expectancy \>3 months.
• 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) \<2.5 X institutional upper limit of normal, creatinine within normal institutional limits
• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Histologically or cytologically confirmed SCLC without MGMT methylation.
• Patients who have received three or more previous chemotherapy lines for small cell lung cancer or radiotherapy on target lesions.
• Symptomatic uncontrolled CNS metastasis.
• Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• Presence of infection.
• History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or other agents used in the study.
• Presence of medical problems of sufficient severity to prevent full compliance with the study.
• 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).

Sponsors & Collaborators

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

Study Sites (8)

Ircc Irst

Meldola, FC, 47014, Italy

Location

Oncologia Medica, Azienda ospedaliera universitaria di Ferrara

Ferrara, FE, 44124, Italy

Location

Oncologia Medica AOU Policlinico di Modena

Modena, MO, 41100, Italy

Location

U.O. Oncologia Medica

Faenza, RA, 48018, Italy

Location

U.O Oncologia medica

Lugo, RA, 48022, Italy

Location

UO Oncologia Medica, Ospedale S.Maria delle Croci

Ravenna, RA, 48121, Italy

Location

U.O Oncologia medica

Rimini, RN, 47923, Italy

Location

Oncologia Medica Ospedale Guglielmo da Saliceto

Piacenza, 29121, Italy

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claudia Casanova, MD

  Oncology Department, PO Ravenna, AUSL della Romagna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

IT (8)