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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT00027833
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic colorectal adenocarcinoma
* No clinically active CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* More than 6 months
Hematopoietic:
* Lymphocyte count at least 1,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST/ALT less than 3 times ULN (5 times ULN if liver metastases present)
* Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present)
* No hepatocellular dysfunction
* No cirrhosis
Renal:
* Creatinine less than 2.5 mg/dL
Cardiovascular:
* No uncontrolled coronary artery disease
* No symptomatic congestive heart failure
Pulmonary:
* No uncontrolled chronic obstructive lung disease
Gastrointestinal:
* No unsolved bowel obstruction or subobstruction
* No uncontrolled Crohn's disease
* No ulcerative colitis
* No concurrent chronic diarrhea
Immunologic:
* HIV negative
* No immunocompromised patients
* No diagnosis of altered immune function, including:
* Lupus erythematosus
* Sjogren's syndrome
* Scleroderma
* Myasthenia gravis
* Goodpasture's disease
* Addison's disease
* Hashimoto's thyroiditis
* Active Graves' disease
* No known allergy to egg products or neomycin
* No prior adverse reaction to tetanus toxoid-containing vaccines
Other:
* No significant comorbid medical function
* No uncontrolled infection
* No unstable diabetes mellitus
* No uncontrolled thyroid function abnormalities
* No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix
* No other medical illness or mental status that would preclude study participation
* No prior severe toxicity to adjuvant chemotherapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior CEA-directed immunotherapy
* No other concurrent immunotherapy
Chemotherapy:
* At least 6 months since prior adjuvant chemotherapy
* No prior chemotherapy for metastatic disease
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent daily use of systemic steroids
* No concurrent nonsubstitutional hormonal therapy
Radiotherapy:
* No prior radiotherapy to more than 50% of all nodal groups
* No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve
Surgery:
* No prior major organ allograft
* Recovered from prior surgery
Other:
* At least 28 days since prior investigational products
* No other concurrent investigational products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00027833
Study Brief:
Protocol Section:
NCT00027833