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:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00397904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Adenocarcinoma or squamous cell carcinoma of the esophagus
* Adenocarcinoma of the gastroesophageal junction
* Adenocarcinoma of the stomach
* Metastatic disease
* Measurable disease by diagnostic CT scan or MRI
* Failed prior treatment with cisplatin and irinotecan hydrochloride, defined by the following:
* Radiographic progression within 12 weeks\* from the last dose of prior cisplatin and irinotecan hydrochloride, administered either as adjuvant or neoadjuvant therapy, OR as therapy for metastatic disease NOTE: \*Prior irinotecan hydrochloride and cisplatin must have been administered within the past 12 weeks; other chemotherapy regimens may have been administered between the time of disease progression or prior irinotecan hydrochloride/cisplatin and study entry
* Pathologic tissue available for immunohistochemistry (IHC) staining for the epidermal growth factor receptor (EGFR)
* Positive or negative EGFR by IHC allowed
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Life expectancy \> 3 months
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Creatinine ≤ 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior severe infusion reaction to a monoclonal antibody
* No history of allergic reactions to compounds of similar chemical or biologic composition to irinotecan hydrochloride, cisplatin, or other study agents
* No prior intolerance to irinotecan hydrochloride or cisplatin despite prior dose attenuations
* No uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection requiring parenteral antibiotics
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Uncontrolled hypertension
* Clinically significant cardiac arrhythmia
* Myocardial infarction within the past 6 months
* HIV infection
* Psychiatric illness or social situations that would preclude study compliance
* No history of Gilbert's disease
* No medical condition or reason that would preclude study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 3 weeks since prior chemotherapy or radiotherapy and recovered
* No more than 2 prior treatment regimens for metastatic disease
* No prior therapy specifically and directly targeting the epidermal growth factor receptor pathway
* No prior anticancer murine or chimeric monoclonal antibody therapy
* Prior humanized monoclonal antibody therapy allowed
* No concurrent antiseizure medications known to affect the metabolism of irinotecan hydrochloride, including phenytoin or phenobarbital
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00397904
Study Brief:
Protocol Section:
NCT00397904