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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00394433
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, unresectable esophageal or gastric carcinoma (carcinoma=adenocarcinoma or squamous cell carcinoma)
* Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or 2 cm or greater by other radiographic technique
* Lesions must be measurable in at least one dimension
* Bone lesions, ascites, and effusions are not measurable
* 18 years of age or older
* ECOG performance status 0 or 1
* Life expectancy of at least 12 weeks
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
Exclusion Criteria:
* Prior chemotherapy (except as part of pre- or post-operative therapy, completed more than 1 year prior to start day of this protocol)
* History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan, or drugs formulated with polysorbate 80
* Current, recent (within 4 weeks) or planned participation in an experimental drug study
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies within 7 days prior to Day 0 of study
* Myocardial infarction or stroke in past 6 months
* Blood pressure of \> 150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) grade II or greater congestive heart failure
* Clinically significant peripheral vascular disease
* Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated transfusions
* Evidence of bleeding diathesis or coagulopathy
* Uncontrolled serious medical or psychiatric illness
* Uncontrolled diarrhea
* Peripheral neuropathy \> grade 1
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Other active malignancy other than non-melanoma skin cancer or in situ cervical carcinoma.
* Urine protein: creatinine ratio of 1.0 or greater at screening
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
* Serious non-healing wound, ulcer, or bone fracture
* Pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00394433
Study Brief:
Protocol Section:
NCT00394433