Trial record 8 of 62 for:    "Carcinoma, Small Cell"

Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

This study is currently recruiting participants.
Verified July 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
yihu, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01900951
First received: July 11, 2013
Last updated: July 13, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Small Cell
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Temozolomide as Maintenance Therapy After Initial Induction Chemotherapy in Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • One-year Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    the Percentage of Patients Who Experience an Objective Benefit From Treatment

  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  • time to progression [ Time Frame: from the start date of treatment until the date of occurrence of progressive disease ] [ Designated as safety issue: No ]
    the interval between the start date of treatment and the date of occurrence of progressive disease


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: Temozolomide

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01900951

Contacts
Contact: yi hu, M.D. +86-01066937878 taohaitao1988@gmail.com

Locations
China, Beijing
PLA general hospital Recruiting
BeiJing, Beijing, China, 100853
Contact: yi hu, M.D.       taohaitao1988@gmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: yi hu, M.D. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: yihu, chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01900951     History of Changes
Other Study ID Numbers: TMS-01
Study First Received: July 11, 2013
Last Updated: July 13, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese PLA General Hospital:
Small cell lung cancer
temozolomide
Maintenance chemotherapy

Additional relevant MeSH terms:
Carcinoma, Small Cell
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014