Phase II Trial of Temozolomide in Patients affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer with MGMT methylation. GOPAV03
- Conditions
- Small Cell Lung CancerMedDRA 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003150-25-IT
- Lead Sponsor
- IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 19
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) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
9.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.
10.Ability to understand and the willingness to sign a written informed consent document.
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: •TTP<br> •OS <br> •Toxicity<br> • Correlation between Response Rate (RR) and level of MGMT promoter methylation and/or BER genes alterations.<br> ;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 Outcome Measures
Name Time Method 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