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FR901228 in Treating Patients With Recurrent Small Cell Lung Cancer
This study has been completed.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00086827
  Purpose

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
Lung Cancer
Drug: romidepsin
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: FR 901228
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Study Start Date: May 2004
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with recurrent small cell lung cancer treated with FR901228(depsipeptide).

Secondary

  • Determine the overall and failure-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer
  • Recurrent disease after 1, and only 1, prior platinum-based chemotherapy regimen (either cisplatin or carboplatin)

    • Completed therapy ≥ 90 days before documentation of relapse
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • The following are considered non-measurable lesions:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in previously irradiated area
  • Treated or controlled brain metastases allowed

    • No requirement for further radiotherapy or steroid therapy to control peri-tumoral edema

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance 60-150 mL/min for males and 60-130 mL/min for females

Cardiovascular

  • LVEF > 40% by MUGA
  • QTc < 500 msec
  • No significant cardiac disease
  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past year
  • No uncontrolled dysrhythmias
  • No poorly controlled angina
  • No left ventricular hypertrophy by echocardiograph or EKG
  • No prior serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • See Disease Characteristics
  • No prior FR901228 (depsipeptide)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormones except for the following:

    • Steroids given for adrenal failure
    • Hormones administered for non-cancer-related conditions (e.g., insulin for diabetes)
    • Intermittent dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery

  • At least 2 weeks since prior major surgery and recovered

Other

  • No concurrent agent that causes QTc prolongation
  • No concurrent enzyme-inducing anticonvulsant drugs (e.g., phenytoin, phenobarbital, carbamazepine, felbamate, or primidone)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent potassium-wasting diuretics (e.g., hydrochlorothiazide)
  • No other concurrent histone deacetylase inhibitors (e.g., phenylbutyrate, valproic acid, or suberoylanilide hydroxamic acid)
  • No other concurrent investigational agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086827

  Show 27 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009