Clinical trial NCT00671645 (phase 2, status: terminated)
Conditions: rectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, bevacizumab
SMILES: CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O
Reason stopped: 
    reaching of step 1 (recruitment of 8 patients) per protocol -> risk assessment -> termination
    because of occurance of toxicity grade 3 and 4
  
Eligibility criteria:

        Inclusion Criteria:

          -  age: 18 - 80

          -  bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to be
             basically surgically complete resectable (->R0).

          -  no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of
             rectum carcinoma

          -  WHO performance status 0-2

          -  adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5 x
             10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)

          -  adequate hepatic function (Bilirubin: <= 1.5 x ULN, GOT und GPT <= 2.5 x ULN)

          -  adequate renal function (creatinin: <= 1.25 mg/dl, creatinin-clearance: > 50 ml/min
             (Cockcroft and Gault formula)), proteinuria: dipstick < 2+. In case of dipstick > 2+
             protein has to be measured in 24h urine and does not exceed more than 1g/24h)

          -  ability of intake of pills

          -  women of childbearing potential: exclusion of pregnancy (negative urin or serum
             pregnancy test)

          -  willingness of women of childbearing potential and accordingly of potent men to use
             approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3
             month after conclusion of the study

          -  life expectancy of at least 3 month

          -  INR and aPTT < 1.5 ULN

          -  signed Informed Consent before recruitment

        Exclusion Criteria:

          -  failure of one inclusion criteria

          -  former radiotherapy of pelvis or abdomen

          -  former chemotherapy

          -  any other kind of malign tumor in the last 5 years

          -  any other kind of tumour in the last 5 years with exception of basal cell carcinoma of
             skin and cervix carcinoma in situ

          -  general contraindication or known hypersensitivity against Bevacizumab and/or
             Capecitabine

          -  non malign disease, if there is a contraindication with radiotherapy, or chemotherapy
             with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled hypertension
             (systolic > 150 mmHG and/or diastolic >100 mmHG) or clinical significant (e.g. active)
             cardiovascular disease: CVA (cardiovascular accident)/ cerebral apoplexy (< 6 months
             before recruitment), myocardial infarct (< 6 months before recruitment), instable
             angina pectoris, CHF with NYHA status II or higher, or treated serious arrhythmia,
             hepatic disease, significant neurologic or psychiatric disorders

          -  florid, serious infections at the time of recruitment

          -  peripheral neuropathy (NCI CTC >= Grade 1)

          -  legally limited contractual capability or evidence of neurological or psychiatric
             disease, if it will constrict the patients compliance in the opinion of the
             investigator

          -  evidence of lacking cooperation of the patient

          -  major intervention within 28 days before recruitment, open wounds

          -  serious injuries, unhealed wounds or fractures

          -  patients with spinal compressions or metastases in central nervous system

          -  evidence of bleeding diathesis or coagulation dysfunction

          -  actual intake of anticoagulant or thrombolytic agents, Aspirin > 325 mg/d or within 10
             days before study start)

          -  actual or recent (within 10 days before recruitment) therapeutic therapy with
             fully-dosed anticoagulants. A prophylactic treatment is permitted.

          -  previous thromboembolic or hemorrhagic events within the last 6 months before
             recruitment

          -  previous abdominal fistulas, GI perforation or intra-abdominal abscess within the last
             6 months

          -  treatment with other study medication within 28 days before recruitment

          -  patients with malabsorption syndrome or difficulties swallowing

          -  pregnant or breast feeding women