Advanced/Recurrent Colorectal Cancer
Conditions
Interventions
cetuximab S-1 combination therapy cetuximab : Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..) S-1 : 60 or 80 mg/m2/2weeks/day1-14, 4w
Sponsors
Kinki university school of medicine Department of clinical oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with histologically proven colorectal cancer, and Unresectable or recurrent colorectal camcer patient who treatment of pallitive radiation can enroll to time that radiaton ended 1 week (2)EGFR protein detected by tumor sample (3)Patient was not treated to cetuximab (4)Age >= 20 and =< 75. (5)ECOG performance status of 0,1,and 2. (6)Patient can be oral ingestion. (7) Unresectable primary tumor or with one or more unresectable metatatic tumor Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) within 30 days before registration. (8)Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration. (9)Resistrar evaluation patients who survive 12 weeks. (10)Patient can be contraception time to therapy ended 3 months. (11)Patient was explain of this trial and put patient's signature to a document.
Exclusion criteria
Exclusion criteria: (1)A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis. (2)A case receiving flucytosine (a pyrimidine system antifungal agent fluoride). (3)A case with a history of serious drug allergy. (4)The case with pleural effusion, ascitic fluid needing treatment such as the drainage and the pericardial fluid. (5) The case with serious heart disorder, myocardial infarction within six months, hypertension having poor control, bacterial infection and fungal infection of the activity and other serious complications (haemorrhage of digestive tract). (6)A case to have a short bowel syndrome merger or diarrhea (watery feces) continuously. (7) Intestinal paralysis, a case with bowel obstruction. (8) Metastases to brain case with the symptom.A case (as for the metastases to brain case that a symptom was stable by metastases to brain case and radiotherapy and medical treatment without the symptom, possible registration) to need the antihydropic including the steroid of the symptom control purpose. (9)A case with the diabetes mellitus inadequate control. (10)The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study. (11)A case to have pregnant or pregnant possibilities, the case that there is not of the intention to prevent conception and the case that we are nursing. (12)In addition, the case that we judged to be inadequate though the medical attendants conducted this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the recomend dose of cetuximab and S-1 combinaton therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics(PK/PD), a time to success treatment, overall survival, tumor response, quality of life | — |
Countries
Japan
Contacts
Public ContactSoichi Fumita
Kinki university school of medicine Department of clinical oncology
Outcome results
None listed