Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

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
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
...
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
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
Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
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
Patients must have measurable disease, this can include brain metastases
Patients must be informed of the investigational nature of this study and sign an informed consent form

Exclusion Criterias

Patients receiving other investigational agents
Patients who are pregnant or breastfeeding
Patients with leptomeningeal involvement
...
Patients receiving other investigational agents
Patients who are pregnant or breastfeeding
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.

Summary

Conditions
Carcinoma, Small Cell
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

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.

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.

Inclusion Criterias

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
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
...
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
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
Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
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
Patients must have measurable disease, this can include brain metastases
Patients must be informed of the investigational nature of this study and sign an informed consent form

Exclusion Criterias

Patients receiving other investigational agents
Patients who are pregnant or breastfeeding
Patients with leptomeningeal involvement
...
Patients receiving other investigational agents
Patients who are pregnant or breastfeeding
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.

Locations

BeiJing, Beijing, 100853
BeiJing, Beijing, 100853

Tracking Information

NCT #
NCT01900951
Collaborators
Not Provided
Investigators
Study Chair: yi hu, M.D. Chinese PLA General Hospital