Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

NCT01900951 | Unknown Phase 2 DMC

• 1 other identifier: TMS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Small Cell

Keywords

Small cell lung cancer; temozolomide; Maintenance chemotherapy

Outcome Measures

Primary Outcomes (1)

• One-year progress free survival

  The Percentage of Patients Who Are Progress Free One Year After Completing Protocol Treatment

  18 months

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  18 months

• Safety

  18 months

• time to progression

  from the start date of treatment until the date of occurrence of progressive disease

Study Arms (1)

Temozolomide

EXPERIMENTAL

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

Drug: Temozolomide

Interventions

Temozolomide DRUG

Temozolomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

PLA general hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Small Cell; Small Cell Lung Carcinoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yi hu, M.D.

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 17, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

CN (1)