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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00017212
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed gastric or gastroesophageal adenocarcinoma
* Lymph node involvement and/or distant metastasis
* No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach
* Measurable disease with indicator lesions outside the field of prior radiotherapy
* At least 20 mm by conventional scan OR
* At least 10 mm by spiral CT scan
* Nonmeasurable lesions include the following:
* Primary tumor
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonitis
* Cystic lesions
* Abdominal masses not confirmed and followed by imaging techniques
* No prior treatment for locally advanced or metastatic disease
* Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9.0 g/dL
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* Albumin at least 2.8 g/dL
* PT or INR no greater than 1.5 times ULN (coumadin independent)
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction within the past 6 months
Other:
* No concurrent serious infection
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No overt psychosis, mental disability, or incompetence that would preclude informed consent
* No other life-threatening illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Biologic therapy:
* No concurrent anti-cancer biologic therapy
* No concurrent prophylactic colony stimulating factors during first course of therapy
Chemotherapy:
* Recovered from prior adjuvant chemotherapy
* No other concurrent anti-cancer chemotherapy
* No other concurrent anti-cancer cytotoxic therapy
Endocrine therapy:
* Concurrent megestrol for appetite stimulation allowed
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No prior wide-field radiotherapy to more than 25% of bone marrow
* No concurrent anti-cancer radiotherapy
Surgery:
* At least 4 weeks since prior major surgery and recovered
* No concurrent anti-cancer surgery
Other:
* No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00017212
Study Brief:
Protocol Section:
NCT00017212