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

NCT00098527 | Terminated Phase 2

• 6 other identifiers: NCI-2012-026376075-04-7R0DUMC-6075-04-7R0CDR0000398177NCI-6351U01CA099118
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Radiographic response rate (complete response & partial response)

  Not Provided

Secondary Outcomes (9)

• Progression-free survival (PFS) according to RECIST

  Up to more than 6 months

• 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

  Up to 12 months

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

  Not Provided

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

  Not Provided

• Toxicity

  Not Provided

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

romidepsin DRUG

Given IV

Also known as: FK228, FR901228, Istodax

Treatment (romidepsin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (romidepsin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Neoplasms; Stomach Neoplasms

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Herbert Hurwitz

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: October 1, 2004
• Primary Completion: September 1, 2005
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

US (1)