Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT00098527
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00098527
Study Brief:
Protocol Section:
NCT00098527