Clinical trial · Interventional
FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers
NCT00098527CI-TRIAL-00011190terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Esophagus | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Stomach | Gastric Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| romidepsin | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (romidepsin)
- description
- 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.
- interventionNames
- Drug: romidepsin
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Radiographic response rate (complete response & partial response)
- timeFrame
- Not Provided
Secondary outcomes (9)
- measure
- Progression-free survival (PFS) according to RECIST
- timeFrame
- Up to more than 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.