Overview
Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
Status:
Unknown status
Unknown status
Trial end date:
2018-01-01
2018-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chinese PLA General HospitalTreatments:
Dacarbazine
Temozolomide
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.