Carcinoma, Small CellPhase 2NCT01900951
Temozolomide as Maintenance Therapy in Small Cell Lung Cancer
A Phase 2 study testing Temozolomide in people with Carcinoma, Small Cell, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Small Cell
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2016
- 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
- Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
- Patients must have measurable disease, this can include brain metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL
- Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × the upper limit of normal (ULN), or AST and ALT <=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin <=1.5 × the ULN; serum creatinine <=1.5 × the ULN
- Women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment
- Patients must be informed of the investigational nature of this study and sign an informed consent form
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients receiving other investigational agents
- Patients with leptomeningeal involvement
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Temozolomide as Maintenance Therapy After Initial Induction Chemotherapy in Small Cell Lung Cancer
Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC.
Read the detailed description
Subjects will receive standard of care treatment for SCLC with added treatment of maintenance temozolomide. Efficacy and safety of temozolomide and one year survival and time to progression of patients will be recorded.
- Conditions
- Carcinoma, Small Cell
- Being tested
- Temozolomide
- Keywords
- Small cell lung cancer, temozolomide, Maintenance chemotherapy
- Medical subject headings
- Carcinoma, Small Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Patients in the study will receive the following for the duration of the study:First-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cycles of therapy for the first-line chemotherapy. After first-line treatment, temozolomide will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
Re-staging will be performed every 2 cycles (every 8 weeks) during the study Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year progress free survival
The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment
Measured: 18 months
Secondary outcomes (3)
Overall Response Rate (ORR)
the Percentage of Patients Who Experience an Objective Benefit From Treatment
Measured: 18 months
Safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 18 months
time to progression
the interval between the start date of treatment and the date of occurrence of progressive disease
Measured: from the start date of treatment until the date of occurrence of progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yihu, Chinese PLA General Hospital
- Investigators
- yi hu, M.D., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900951
- Sponsor's protocol ID
- TMS-01
- Status last verified
- Jan 2016
- First submitted
- 11 Jul 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Temozolomide as Maintenance Therapy After Initial Induction Chemotherapy in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01900951
- Acronym / sponsor ID
- TMS-01
- Conditions
- Carcinoma, Small Cell
- Keywords
- Small cell lung cancer, temozolomide, Maintenance chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Jul 2013 (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.
Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC.
Detailed description
Subjects will receive standard of care treatment for SCLC with added treatment of maintenance temozolomide. Efficacy and safety of temozolomide and one year survival and time to progression of patients will be recorded.
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: TemozolomidePatients in the study will receive the following for the duration of the study:First-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cycles of therapy for the first-line chemotherapy. After first-line treatment, temozolomide will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs. Re-staging will be performed every 2 cycles (every 8 weeks) during the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
- Patients must have measurable disease, this can include brain metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL
- Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × the upper limit of normal (ULN), or AST and ALT <=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin <=1.5 × the ULN; serum creatinine <=1.5 × the ULN
Key exclusion criteria (5 listed)
- Patients who are pregnant or breastfeeding
- Patients receiving other investigational agents
- Patients with leptomeningeal involvement
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
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 |
|---|---|---|
| Temozolomide | Drug | Temozolomide |
Primary outcome
One-year progress free survival
Time frame: 18 months
The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: 18 months
Safety
Time frame: 18 months
time to progression
Time frame: from the start date of treatment until the date of occurrence of progressive disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Related trials for Carcinoma, Small Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
yi hu, M.D. study chair
Chinese PLA General Hospital
1 site 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 Carcinoma, Small Cell, run by Chinese PLA General Hospital at 1 site in China.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
One-year progress free survival (time frame: 18 months). 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 26 Jan 2016.