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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00086827 |
RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with recurrent small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: romidepsin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Single Agent Depsipeptide (FK228)(NSC630176; 51,810) In Relapsed Small Cell Lung Cancer |
Study Start Date: | May 2004 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have continuing tumor response or stable disease after 6 courses receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-36 patients will be accrued for this study within 4-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Recurrent disease after 1, and only 1, prior platinum-based chemotherapy regimen (either cisplatin or carboplatin)
Measurable disease
The following are considered non-measurable lesions:
Treated or controlled brain metastases allowed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormones except for the following:
Radiotherapy
Surgery
Other
Study Chair: | Gregory A. Otterson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000371616, CALGB-30304 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00086827 |
Health Authority: | United States: Federal Government |
recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Romidepsin Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Antibiotics, Antineoplastic Pharmacologic Actions |