Carcinoma, Small Cell
Conditions
Keywords
Small cell lung cancer, temozolomide, Maintenance chemotherapy
Brief 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.
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.
Interventions
DRUGTemozolomide
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year progress free survival | 18 months | The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to progression | from the start date of treatment until the date of occurrence of progressive disease | the interval between the start date of treatment and the date of occurrence of progressive disease |
| Overall Response Rate (ORR) | 18 months | the Percentage of Patients Who Experience an Objective Benefit From Treatment |
| Safety | 18 months | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Countries
China
Outcome results
None listed