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Adenocarcinoma of the EsophagusPhase 2NCT00098527

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

A Phase 2 study testing romidepsin and laboratory biomarker analysis in people with Adenocarcinoma of the Esophagus and Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
romidepsin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2004to Sep 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
romidepsin, laboratory biomarker analysis
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • romidepsinDrug

    Also called FK228, FR901228, Istodax

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00098527
Study groupRoleWhat they receive
Treatment (romidepsin)ExperimentalPatients 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.
Receives: Drug: romidepsin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic response rate (complete response & partial response)

    Measured: Not Provided

Secondary outcomes (9)

  1. Progression-free survival (PFS) according to RECIST

    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.

    Measured: Up to more than 6 months

  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

    Measured: Up to 12 months

  3. Correlation of changes in gene expression profile in dermal granulation tissue pre- and post-treatment with gene expression profile

    Measured: Not Provided

  4. Correlation of wound vascular scores pre- and post-treatment with gene/protein changes

    Measured: Not Provided

  5. Toxicity

    Measured: Not Provided

  6. Changes in gene expression profile

    Measured: At pre- and post-treatment

  7. Changes in levels of p21 and thymidine kinase expression, and tubulin acetylation using Western blotting

    Measured: From baseline to 3 weeks

  8. Changes in gene expression profile in dermal granulation tissue

    Measured: From baseline to up to 3 weeks

  9. Change in plasma and urine TGFB levels

    Measured: At pre-and post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098527
Sponsor's protocol ID
NCI-2012-02637
Other IDs
6075-04-7R0, DUMC-6075-04-7R0, CDR0000398177, NCI-6351, U01CA099118
Status last verified
Jul 2013
First submitted
7 Dec 2004
Last updated
2 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing romidepsin and laboratory biomarker analysis in people with Adenocarcinoma of the Esophagus and Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 53 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic response rate (complete response & partial response) (time frame: Not Provided). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.

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