Back to resultsTemozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
Primary Purpose
Extensive-stage Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Temozolomide
first-line chemotherapy
Prophylactic cranial irradiation
thoracic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer focused on measuring Small Cell Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
- the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BSC group
TMZ group
Arm Description
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. Radiotherapy was allowed. Follow-up until disease progression.
Patients will receive platinum-based first-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cyclesfor 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, radiotherapy was allowed.
Outcomes
Primary Outcome Measures
PFS of the maintenance therapy
from the data of randomized to the date of disease progression or the patient dies
Secondary Outcome Measures
PFS
from the date of first-line chemotherapy to the date of disease progression
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02772107
Brief Title
Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small Cell Lung Cancer
Keywords
Small Cell Lung Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BSC group
Arm Type
Experimental
Arm Description
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. Radiotherapy was allowed. Follow-up until disease progression.
Arm Title
TMZ group
Arm Type
Experimental
Arm Description
Patients will receive platinum-based first-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cyclesfor 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, radiotherapy was allowed.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Temozolomide is a nonclassic oral alkylating agent. Temozolomide will be given alone as maintenance therapy in 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.
Intervention Type
Drug
Intervention Name(s)
first-line chemotherapy
Intervention Description
first-line chemotherapy must be platinum-based: cisplatin(75mg/m2 for d1) or carboplatin（AUC 5 for d1) combined with etoposide（100mg/m2 for d1-d3）
Intervention Type
Radiation
Intervention Name(s)
Prophylactic cranial irradiation
Intervention Description
Prophylactic cranial irradiation was allowed if necessary
Intervention Type
Radiation
Intervention Name(s)
thoracic radiotherapy
Intervention Description
thoracic radiotherapy was allowed if necessary
Primary Outcome Measure Information:
Title
PFS of the maintenance therapy
Description
from the data of randomized to the date of disease progression or the patient dies
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PFS
Description
from the date of first-line chemotherapy to the date of disease progression
Time Frame
2 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yi hu, PhD
Phone
+861066937292
Email
13718994934@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
haitao tao, PhD
Phone
+861066937875
Email
whatyouknow@126.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haitao tao, PhD
Phone
+861066937875
Email
whatyouknow@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
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