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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00632203 |
The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung Adenocarcinoma Carcinoma, Large Cell Carcinoma, Squamous Cell |
Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase 2 Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Temozolomide treatment: Experimental
Subjects will receive temozolomide at a dose of 75 mg/m2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
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Drug: Temozolomide
5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
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Observation: No Intervention
Observation
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This is a Phase 2, open-label, randomized, multicenter study of maintenance temozolomide versus observation in subjects with stable or responding stage III/IV NSCLC to be conducted in conformance with Good Clinical Practices. Subjects will be randomly assigned to a study drug (temozolomide) or observation arm. The study drug will be administered at a dose of 75 mg/m2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first. Subjects completing 6 cycles of treatment will be followed up for incidence of brain metastasis for up to 2 years, or until progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05146 |
Study First Received: | February 29, 2008 |
Last Updated: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00632203 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Temozolomide Carcinoma Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Large Cell Non-small Cell Lung Cancer |
Antineoplastic Agents, Alkylating Neoplasms, Squamous Cell Carcinoma, Squamous Cell Adenocarcinoma Alkylating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Temozolomide Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases |
Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Large Cell Antineoplastic Agents, Alkylating Neoplasms, Squamous Cell Adenocarcinoma Carcinoma, Squamous Cell Alkylating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |