Clinical trial NCT01900951: Temozolomide as Maintenance Therapy in Small Cell Lung Cancer
Official title: Phase 2 Study of Temozolomide as Maintenance Therapy After Initial Induction Chemotherapy in Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Small Cell
Keywords: Small cell lung cancer
temozolomide
Maintenance chemotherapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: One-year progress free survival
timeFrame: 18 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 18 months
measure: Safety
timeFrame: 18 months
measure: time to progression
timeFrame: from the start date of treatment until the date of occurrence of progressive disease
Other outcomes:
Locations:
city: BeiJing
country: China
facility: PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: yi hu, M.D.
role: STUDY_CHAIR
References: