Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

Carcinoma, Small Cell Clinical Trial

Official title:

Phase 2 Study of Temozolomide as Maintenance Therapy After Initial Induction Chemotherapy in Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01900951
• Other study ID #: TMS-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 11, 2013
• Last updated: January 24, 2016
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Small Cell Lung Carcinoma

Intervention

Drug:
• Temozolomide

Locations

Country	Name	City	State
China	PLA general hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year progress free survival	The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment	18 months	No
Secondary	Overall Response Rate (ORR)	the Percentage of Patients Who Experience an Objective Benefit From Treatment	18 months	No
Secondary	Safety	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	18 months	No
Secondary	time to progression	the interval between the start date of treatment and the date of occurrence of progressive disease	from the start date of treatment until the date of occurrence of progressive disease	No