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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00062257
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed gastric adenocarcinoma
* Recurrent or metastatic disease
* Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction
* Measurable disease
* At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active disseminated intravascular coagulation
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)
* Alkaline phosphatase no greater than 5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No other uncontrolled concurrent illness that would preclude study participation
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Must have central or peripherally inserted central catheter
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa
Chemotherapy
* No prior chemotherapy for recurrent or metastatic disease
* Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy and recovered
Surgery
* Not specified
Other
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00062257
Study Brief:
Protocol Section:
NCT00062257