Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer

You may be eligible if

• 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