Status:
TERMINATED
FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Esophagus
Adenocarcinoma of the Stomach
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 differen...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00098527
Start Date
October 1 2004
Last Update
July 2 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710