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A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer

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Trial Information

A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers


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

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

- No concurrent hydrochlorothiazide

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiographic response rate (complete response & partial response)

Outcome Time Frame:

Not Provided

Safety Issue:


Principal Investigator

Herbert Hurwitz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Stomach
  • Recurrent Esophageal Cancer
  • Recurrent Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Duke University Medical Center Durham, North Carolina  27710