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

NCT ID: NCT00098527

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31

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.

Detailed Description

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

Conditions

Adenocarcinoma of the Esophagus; Adenocarcinoma of the Stomach; Recurrent Esophageal Cancer; Recurrent Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

romidepsin

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

romidepsin

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

FK228; FR901228; Istodax

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert Hurwitz

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

6075-04-7R0

Identifier Type: -

Identifier Source: secondary_id

DUMC-6075-04-7R0

Identifier Type: -

Identifier Source: secondary_id

CDR0000398177

Identifier Type: -

Identifier Source: secondary_id

NCI-6351

Identifier Type: -

Identifier Source: secondary_id

U01CA099118

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02637

Identifier Type: -

Identifier Source: org_study_id