advanced/recurrent colon cancer or rectal cancer
Conditions
Interventions
Carbamazepin is administered during FOLFOX therapy. Carbamazepin tablet 100mg, 200mg or granule including Car. 500mg in 1000mg
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) colon cancer or rectal cancer, histologically (2) eligible in the both patients with prior therapy and without any prior therapy (3) eligible in the both patients with and without measurable lesions (4) age between >= 20 years old and <= 75 years old (5) with the expected survival period more than 12 weeks (6) more than 4 weeks after surgical operation (7) Performance Status (ECOG) 0-1 (8) without any disorder in the important organs and with good results of the Examinations seven days before the registeration WBC: 3,000 &#8211; 12,000 /mm3 Neutrocyte: more than 1,500/mm3 Platelet: more than 100,000/mm3 s Total Bil: within 1.5 times of normal range sAST, sALT, sALP: within 2.5 times of normal range s Creatinin: within the normal range (9) written informed consent (10) patients who can take food orally
Exclusion criteria
Exclusion criteria: (1) Patients who received transfusion, blood components or GCSF within seven days Before registration (2) with brain metastasis (3) with much cavity fluid to be removed (4) with active double cancer (5) allergy against medicines (6) uncontrolled Hypertension (7) receiving digitalis (8) uncontrolled DM (9) active infectious disease (10) watery diarrhea (11) disorder on EKG (12) severe respiratory diseases (interstitial pneumonitis, pulmonary fibrosis, Severe pulmonary emphysema) (13) psychiatric disorder (14) fresh bleeding on the digestive tract (15) sensory nerve disorder (16) pregnant and/or nursing women (17) driving a complicated mechanism or vehicle (18) Doctors' stop not to be registered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the feasibility of Carmazepin therapy and to evaluate whether Carmazepin has the protective and/or prophylactic effects against peripheral nerve syndrome due to FOLFOX therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Median dose of L-OHP, nerve disorder at the end of FOLFOX, Course, PFS and TTF, Response Rate | — |
Countries
Japan
Outcome results
None listed