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FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098527
Recruitment Status : Terminated
First Posted : December 8, 2004
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well FR901228 works in treating patients with refractory stomach cancer or gastroesophageal junction. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Esophagus Adenocarcinoma of the Stomach Recurrent Esophageal Cancer Recurrent Gastric Cancer Drug: romidepsin Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the radiographic response rate (complete response and partial response) in patients with refractory adenocarcinoma of the stomach or gastroesophageal junction treated with FR901228 (depsipeptide).


I. Determine the median time to progression and progression-free survival of patients treated with this drug.

II. Determine the grade 3 and 4 toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 6.5-10 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers
Study Start Date : October 2004
Actual Primary Completion Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: Treatment (romidepsin)
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: romidepsin
Given IV
Other Names:
  • FK228
  • FR901228
  • Istodax

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Radiographic response rate (complete response & partial response) [ Time Frame: Not Provided ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) according to RECIST [ Time Frame: Up to more than 6 months ]
    The median time to progression and median PFS for all eligible patients, along with their CIs, will be reported. The Kaplan-Meier analysis approach may be used to summarize these time-to-event endpoints.

  2. Frequency of treatment related grade 1-4 toxicities and cardiac toxicities as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 12 months ]
  3. Correlation of changes in gene expression profile in dermal granulation tissue pre- and post-treatment with gene expression profile [ Time Frame: Not Provided ]
  4. Correlation of wound vascular scores pre- and post-treatment with gene/protein changes [ Time Frame: Not Provided ]
  5. Toxicity [ Time Frame: Not Provided ]
  6. Changes in gene expression profile [ Time Frame: At pre- and post-treatment ]
  7. Changes in levels of p21 and thymidine kinase expression, and tubulin acetylation using Western blotting [ Time Frame: From baseline to 3 weeks ]
  8. Changes in gene expression profile in dermal granulation tissue [ Time Frame: From baseline to up to 3 weeks ]
  9. Change in plasma and urine TGFB levels [ Time Frame: At pre-and post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Refractory* to at least 1, but no more than 3, of the following first-line agents:

    • Fluoropyrimidine (e.g., capecitabine or fluorouracil)
    • Taxane (e.g., paclitaxel or docetaxel)
    • Platinum (e.g., carboplatin, cisplatin, or oxaliplatin)
  • No known active brain metastases

    • Treated brain metastases allowed provided metastases are stable off steroids for ≥ 30 days
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 3 months
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine clearance ≥ 50 mL/min
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within the past 6 months
  • No ventricular arrhythmias requiring medication
  • No angioplasty or vascular stenting within the past 3 months
  • No unstable angina
  • No left ventricular hypertrophy by EKG
  • No known history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • QTc < 500 msec
  • LVEF > 40% by MUGA or echocardiogram
  • No other significant cardiac disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Potassium ≥ 4.0 mmol/L (stable level with no change in supplementation within the past 2 weeks)
  • Magnesium ≥ 2.0 mg/dL (stable level with no change in supplementation within the past 2 weeks)
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • Prior biological agents allowed
  • No concurrent prophylactic filgrastim (G-CSF)
  • No concurrent biologic therapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • Prior targeted agents allowed
  • No other prior or concurrent cytotoxic agents
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent medications causing QTc prolongation
  • No concurrent potassium supplementation > 40 mg/day or magnesium supplementation > 1 g/week
  • No concurrent hydrochlorothiazide
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00098527

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Herbert Hurwitz Duke University
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00098527    
Other Study ID Numbers: NCI-2012-02637
U01CA099118 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2004    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents