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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00003558
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of any differentiation grade
* Excludes the following "treatable" conditions:
* Axillary node involvement
* Peritonitis carcinomatosis
* Blastic bone metastases and/or elevated PSA
* Squamous cell cancer with cervical or inguinal presentation
* Poorly differentiated carcinoma
* Neuroendocrine tumors OR
* Tumors located in the mediastinum, retroperitoneum, or nodes
* At least one measurable metastatic site
* No brain or meningeal metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Hematopoietic:
* Leukocyte count at least 4,000/mm3
* Thrombocyte count at least 100,000/mm3
Hepatic:
* Bilirubin less than 1.4 mg/dL
* AST and ALT less than 3 times upper limit of normal
* No cirrhosis of the liver
Renal:
* Creatinine less than 1.7 mg/dL
Cardiovascular:
* At least 3 months since myocardial infarction
* No congestive heart failure, tachydysrhythmia, or unstable angina pectoris
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No active infection
* No other serious illness or medical condition
* No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow)
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003558
Study Brief:
Protocol Section:
NCT00003558