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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019825 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer |
Drug: decitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients |
Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study for each stratification group. Patients are stratified according to number of prior therapies (2 or fewer vs 3 or more).
Patients receive decitabine IV continuously on days 1-3. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of the second course receive 2 additional courses.
Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined for a particular stratum, additional patients from that stratum are treated at the MTD.
Patients are followed for 1 month.
PROJECTED ACCRUAL: A maximum of 72 patients (36 per stratum) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Extrathoracic metastatic disease allowed if no evidence of active intracranial or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Any of the following conditions require clearance by a cardiologist:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |
Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000067228, NCI-99-C-0129, NCI-T99-0012 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00019825 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer extensive stage small cell lung cancer |
recurrent small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer malignant pleural effusion |
Thoracic Neoplasms Antimetabolites Gastrointestinal Diseases Esophageal Neoplasms Pleural Effusion, Malignant Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Digestive System Neoplasms Esophageal Cancer Decitabine Recurrence Carcinoma, Small Cell |
Pleural Effusion Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Mesothelioma Non-small Cell Lung Cancer Esophageal Diseases Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Neoplasms, Mesothelial Esophageal Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasm Metastasis |
Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Decitabine Pharmacologic Actions Neoplasms Digestive System Diseases Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Mesothelioma Esophageal Diseases Adenoma Neoplasms, Glandular and Epithelial |