Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer

Extensive-stage Small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772107
• Other study ID #: 301PLAGH
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 7, 2016
• Last updated: May 12, 2016
• Start date: December 2015
• Est. completion date: January 2018

Study information

• Verified date: May 2016
• Source: Chinese PLA General Hospital
• Contact: yi hu, PhD
• Phone: +861066937292
• Email: 13718994934[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: January 2018
• Est. primary completion date: June 2017
• 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

• the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Temozolomide
Temozolomide is a nonclassic oral alkylating agent. Temozolomide will be given alone as maintenance therapy in 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.

Locations

Country	Name	City	State
China	Chinese 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	PFS of the maintenance therapy	from the data of randomized to the date of disease progression or the patient dies	2 years	No
Secondary	PFS	from the date of first-line chemotherapy to the date of disease progression	2 years	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	2 years	Yes