patients with advanced/recurrent colon cancer who cannot undergo common protocol
Conditions
Interventions
l-LV 250 mg/m2 IV over 2 hours, followed by a slow IV dose of 5-FU 600 mg/m2 during the first hour. This is repeated three times each week and the drug is withdrawn for one week. Dosing will be repeat
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) colon cancer diagnosed pathologically 2) primary advanced colon cancer and/or metastatic colon cancer 3) with measurable lesion 4) without any prior chemotherapy or with 180 days period after postoperative chemotherapy 5) expected more than 3 months of survival 6) patients without any severe disorder in bone marrow, lung, liver, or kidney and satisfies the body conditions 1. Hb >= 9.0g/dL 2. WBC 4,000-12,000/mm3 3. Neutrocyte >= 1,500mm3 4. platelet >= 100,000/mm3 5. Total-bilirubin <= 1.5 mg/dL 6. AST, ALT >= 100U/L or 200U/L for patients with liver metastasis 7. sCr <= 1.2mg/dL 8. CCR >= 50mL/min [Cockcroft-Gault]expected=[(140 - age)x body weight]/[72 x sCr] 7) with normal ECG within 28 days 8) IC form written by patient 9) patients who have at least one of these functions 1. Patients cannot be registered for l-OHP/CPT-11 therapy by a doctor 2. ECOG PS 1-2 3. age >= 65 years old 4. sAlb < 3.5 g/dl 5. prior radiation therapy for pelvic/abdominal lesions
Exclusion criteria
Exclusion criteria: 1) ECOG PS 3-4 2) with a brain tumor or brain metastasis 3) with double cancer diagnosed within 5 years except for basal cell Carcinoma, CIS of portion, and/or CIS of digestive tract treated curatively 4) with a symptom of neuro-vascular disorder on the brain 5) without surgical treatment, open biopsy, and/or suturing of injury 6) with plans of surgical operation during this regimen 7) with easy bleeding and/or coagulation disorder 8) with a history of thrombosis 9) with an ulcer on the digestive tracts which is uncontrollable 10) with inflammation of abdominal organs 11) with a disorder of the kidney which needs some therapies 12) with an uncontrolled hypertension 13) with a severe allergy to fluorouracil. Levohorinate calcium 14)patients with a lack of enzyme; DPD (dihydropyridine dehydrogenase) or with adverse events due to fluoropyrimidine 15) with an uncontrollable diarrhea 16) with interstitial pneumonia or pulmonary fibrosis 17) patients who need immuno-suppressive medicines after an organ transplantation 18) with an uncontrollable infection 19) pregnant females, nursing mothers, or pregnancy test-positive females 20) males who do not protect against pregnancy 21) patients whose doctor cannot register for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, and their grades Progression-Free Survival (PFS) Overall Survival (OS) Incidence of Completion of the regimen | — |
Countries
Japan
Contacts
Public ContactTakeshi Kato
Mino City Hospital Dpt.Surgery
Outcome results
None listed