Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

NCT ID: NCT01900951

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Carcinoma, Small Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

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. 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

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Interventions

Temozolomide

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

yihu

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yi hu, M.D.

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

PLA general hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TMS-01

Identifier Type: -

Identifier Source: org_study_id