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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098644 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as FR901228 and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving FR901228 together with flavopiridol may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of FR901228 when given together with flavopiridol in treating patients with advanced lung, esophageal, or pleural cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer |
Drug: alvocidib Drug: romidepsin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study Of Sequential Depsipeptide/Flavopiridol Infusion for Malignancies Involving Lungs, Esophagus, Pleura or Mediastinum |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2004 |
| Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of FR901228 (depsipeptide).
Patients receive FR901228 IV over 4 hours followed by flavopiridol IV continuously over 72 hours beginning on days 1 and 15. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Six additional patients receive treatment at the MTD.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced malignancy of 1 of the following types:
Primary small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC)
Esophageal cancer
Cancer of nonthoracic origin with metastases to the lungs or pleura
Intracranial or leptomeningeal metastases allowed provided the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No known cardiac abnormalities including any of the following:
Any cardiac arrhythmia requiring antiarrhythmic medication
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Clinical Trials Office - NCI - Center for Cancer Research 888-624-1937 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
More Information
| Study ID Numbers: | CDR0000398184, NCI-05-C-0010, NCI-5987 |
| Study First Received: | December 7, 2004 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098644 History of Changes |
| Health Authority: | Unspecified |
|
extensive stage small cell lung cancer recurrent non-small cell lung cancer recurrent small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer advanced malignant mesothelioma |
recurrent malignant mesothelioma recurrent esophageal cancer stage III esophageal cancer stage IV esophageal cancer lung metastases malignant pleural effusion |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Neoplasms, Mesothelial Esophageal Neoplasms Physiological Effects of Drugs Antibiotics, Antineoplastic Protein Kinase Inhibitors Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Neoplasm Metastasis Growth Inhibitors Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Romidepsin Enzyme Inhibitors Pharmacologic Actions Flavopiridol Neoplasms Digestive System Diseases Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms |