Clinical trial NCT00389870 (phase 3, status: unknown status)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cyclosporine, irinotecan hydrochloride
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of colorectal adenocarcinoma meeting 1 of the following criteria:

               -  Previous or current histologically confirmed primary adenocarcinoma of the colon
                  or rectum and clinical/radiological evidence of advanced or metastatic disease

               -  Histologically or cytologically confirmed metastatic adenocarcinoma with clinical
                  or radiological evidence of colorectal primary tumor

          -  Unidimensionally measurable disease

          -  Disease progression during or after prior fluorouracil with or without oxaliplatin
             therapy and/or with or without bevacizumab

               -  Adjuvant therapy and/or prior therapy for advanced disease allowed

          -  No clinical or radiological evidence of pleural effusion or ascites causing ≥ grade 2
             dyspnea

          -  No clinical or radiological evidence of biliary obstruction

          -  No known CNS metastases or carcinomatous meningitis

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Hemoglobin > 10.0 g/dL

          -  WBC > 3,000/mm³

          -  Platelet count > 100,000/mm³

          -  Glomerular filtration rate > 50 mL/min OR EDTA clearance > 60 mL/min

          -  Bilirubin < 1.46 mg/dL

          -  Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  No history of Gilbert's syndrome

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  Capable of completing quality of life questionnaires

          -  No prior anaphylactic allergic reaction to cetuximab

          -  No other prior or concurrent cancer (excluding nonmelanomatous skin cancer)

          -  No unresolved bowel obstruction, uncontrolled gastrointestinal infection, chronic
             enteropathy (e.g., Crohn's disease or ulcerative colitis), or chronic diarrhea (≥ 4
             stools per day) of any cause

          -  No recent history of seizures

          -  No clinical or radiological evidence of interstitial pneumonitis or pulmonary
             fibrosis,

          -  Capable of reliable oral self-medication

          -  No other condition that would make the patient unsuitable for participation in this
             study

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No major thoracic or abdominal surgery within the past 4 weeks

          -  No systemic anticancer therapy within the past 3 weeks

          -  No prior irinotecan hydrochloride

          -  No grapefruit juice within 3 days before and after each chemotherapy treatment

          -  No experimental drug therapy or antibody therapy, other than cetuximab, within the
             past 6 weeks

          -  No systemic chemotherapy and/or cetuximab within the past 3 weeks

          -  No antifungals or antibiotics within the past 5 days

          -  No ongoing requirement for cyclosporine or any other medication including, but not
             limited to, the following:

               -  Ketoconazole, fluconazole, itraconazole

               -  Erythromycin, clarithromycin, norfloxacin

               -  Diltiazem hydrochloride, verapamil, amiodarone hydrochloride

               -  Fluvoxamine