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Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

Primary Purpose

Carcinoma, Small Cell

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Small cell lung cancer, temozolomide, Maintenance chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PLA general hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

One-year progress free survival
The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment

Secondary Outcome Measures

Overall Response Rate (ORR)
the Percentage of Patients Who Experience an Objective Benefit From Treatment
Safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time to progression
the interval between the start date of treatment and the date of occurrence of progressive disease

Full Information

First Posted
July 11, 2013
Last Updated
January 24, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01900951
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell
Keywords
Small cell lung cancer, temozolomide, Maintenance chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Primary Outcome Measure Information:
Title
One-year progress free survival
Description
The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
the Percentage of Patients Who Experience an Objective Benefit From Treatment
Time Frame
18 months
Title
Safety
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
18 months
Title
time to progression
Description
the interval between the start date of treatment and the date of occurrence of progressive disease
Time Frame
from the start date of treatment until the date of occurrence of progressive disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yi hu, M.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PLA general hospital
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

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Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

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