Small Cell Lung Cancer RecurrentPhase 2TeResNCT02477813
Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation
A Phase 2 study testing Temozolomide in people with Small Cell Lung Cancer Recurrent, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Recurrent
- What is being tested?
- Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 8 sitesItaly
- Study dates
- Jan 2015to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
U.O. Oncologia Medica
Faenza, RA, 48018
Oncologia Medica, Azienda ospedaliera universitaria di Ferrara
Ferrara, FE, 44124
U.O Oncologia medica
Lugo, RA, 48022
Ircc Irst
Meldola, FC, 47014
Oncologia Medica AOU Policlinico di Modena
Modena, MO, 41100
Oncologia Medica Ospedale Guglielmo da Saliceto
Piacenza, 29121
UO Oncologia Medica, Ospedale S.Maria delle Croci
Ravenna, RA, 48121
U.O Oncologia medica
Rimini, RN, 47923
About this study
Official title: Phase II Trial of Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation (TeRes). GOPAV03
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.
Read the detailed description
This is a single-arm, open-label, phase II study. Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC), both limited or extensive disease, relapsed after one or two prior chemotherapy regimens MGMT promoter methylation status will be evaluated on a histological tissue sample (after patient signature of a specific informed consent form for this biological evaluation) using Pyrosequencing technique and the main 10 CpG islands of MGMT promoter will be studied. Only patients with MGMT promoter methylation will be enrolled in the clinical trial. To be eligible patients may have received 1 or 2 prior chemotherapeutic regimens. Patients with brain metastases may be enrolled.
Patients will be informed about the palliative nature of the treatment . Patients will be treated with oral Temozolomide 200 mg/m2/die for 5 consecutive days .
Treatment will be repeated every 28 days and continued until disease progression, intolerable toxicity or patient refusal.
Response to chemotherapy will be monitored every three cycles by CT scan of the chest and the abdomen and computed tomography scan or magnetic resonance imaging of the whole brain. Response to treatment will be evaluated according to RECIST 1.1 criteria.
In case of progressive disease (PD) the patients will discontinue treatment. In case of stable disease (SD), partial response (PR) or complete response (CR) patients continue treatment until disease progression, intolerable toxicity or patient refusal.
After the end of treatment, if disease progression will not occur, patients will be evaluated every 3 months by CT scan of the chest and the abdomen and CT scan or RM of the whole brain until disease progression.
Planned follow-up visits will continue until disease progression and patients will be monitored for survival and toxicity .
- Conditions
- Small Cell Lung Cancer Recurrent
- Being tested
- Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
200 mg/m2 die for 5 consecutive days every 28 days. Treatment will be continued until tumor progression, intolerable toxicity or patient refusal
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR):
The percentage of patients whose cancer achieve either a partial response or a complete response
Measured: from randomization up to 3 years
Secondary outcomes (2)
Time to tumor progression (TTP)
It is defined as the time from registration until objective tumor progression NOT including death. Patients died for any cause or who are lost at follow up are censored.
Measured: from randomization up to 36 months
Overall survival time (OS):
Time from enrolment to the date of death. For subjects with no known date of death, survival time will be censored at the date of their last on-study assessment.
Measured: from randomization up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018
- Study completionJun 2018
Why it stopped: Lack of eligible patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Casanova, MD, Principal investigator, Oncology Department, PO Ravenna, AUSL della Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477813
- Sponsor's protocol ID
- IRST162.09
- Acronym
- TeRes
- Status last verified
- Nov 2018
- First submitted
- 16 Jun 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation (TeRes). GOPAV03
- ClinicalTrials.gov ID
- NCT02477813
- Acronym / sponsor ID
- TeRes / IRST162.09
- Conditions
- Small Cell Lung Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-arm, open-label, phase II study. Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC), both limited or extensive disease, relapsed after one or two prior chemotherapy regimens MGMT promoter methylation status will be evaluated on a histological tissue sample (after patient signature of a specific informed consent form for this biological evaluation) using Pyrosequencing technique and the main 10 CpG islands of MGMT promoter will be studied. Only patients with MGMT promoter methylation will be enrolled in the clinical trial. To be eligible patients may have received 1 or 2 prior chemotherapeutic regimens. Patients with brain metastases may be enrolled.
Patients will be informed about the palliative nature of the treatment . Patients will be treated with oral Temozolomide 200 mg/m2/die for 5 consecutive days .
Treatment will be repeated every 28 days and continued until disease progression, intolerable toxicity or patient refusal.
Response to chemotherapy will be monitored every three cycles by CT scan of the chest and the abdomen and computed tomography scan or magnetic resonance imaging of the whole brain. Response to treatment will be evaluated according to RECIST 1.1 criteria.
In case of progressive disease (PD) the patients will discontinue treatment. In case of stable disease (SD), partial response (PR) or complete response (CR) patients continue treatment until disease progression, intolerable toxicity or patient refusal.
After the end of treatment, if disease progression will not occur, patients will be evaluated every 3 months by CT scan of the chest and the abdomen and CT scan or RM of the whole brain until disease progression.
Planned follow-up visits will continue until disease progression and patients will be monitored for survival and toxicity .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: Temozolomideoral Temozolomide 200 mg/m2/die for 5 consecutive days, every 28 days.Treatment will be continued until tumor progression, intolerable toxicity or patient refusal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temozolomide200 mg/m2 die for 5 consecutive days every 28 days. Treatment will be continued until tumor progression, intolerable toxicity or patient refusal | Drug | Temozolomide |
Primary outcome
Overall Response Rate (ORR):
Time frame: from randomization up to 3 years
The percentage of patients whose cancer achieve either a partial response or a complete response
2 secondary outcomes
Time to tumor progression (TTP)
Time frame: from randomization up to 36 months
Overall survival time (OS):
Time frame: from randomization up to 36 months
Results and safety
The study was stopped early (reason given: Lack of eligible patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Casanova, MD principal investigator
Oncology Department, PO Ravenna, AUSL della Romagna
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Small Cell Lung Cancer Recurrent, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of eligible patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR): (time frame: from randomization up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.