Clinical trial NCT00321685 (phase 2, status: completed)
Conditions: rectal adenocarcinoma, stage ii rectal cancer ajcc v7, stage iii rectal cancer ajcc v7
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: capecitabine, fluorouracil, leucovorin calcium, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed, locally advanced, non-metastatic primary
             T3 or T4 adenocarcinoma of the rectum

          -  Patients must not have evidence of tumor outside of the pelvis including liver
             metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy

          -  Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment
             to the pelvis

          -  The distal border of the tumor must be at or below the peritoneal reflection, defined
             as within 12 centimeters of the anal verge by proctoscopic examination

          -  Transmural penetration of tumor through the muscularis propria must be demonstrated by
             either of the following: computed tomography (CT) scan plus endorectal ultrasound, or
             a magnetic resonance imaging (MRI); an endorectal coil or pelvic MRI is allowed

          -  For the patient to be eligible, the surgeon must prospectively define the tumor as
             either initially resectable or potentially resectable after pre-operative
             chemoradiation; clinically resectable tumors are defined as completely resectable with
             negative margins based on routine examination of the non-anesthetized patient;
             patients whose tumors are not resectable are not eligible; before pre-operative (op)
             treatment, the surgeon should estimate and record the type of resection anticipated:
             pelvic exenteration, posterior pelvic exenteration, APR, LAR, or LAR/coloanal
             anastomosis

          -  Patients with tumors that are clinically fixed, clinical stage T4N0-2, M0 are eligible
             if it is believed that their tumors are potentially resectable after chemoradiation;
             based on the following:

               -  Clinically fixed tumors on rectal examination with tumor adherent to the pelvic
                  sidewall or sacrum

               -  Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack
                  of clear tissue plane will be considered evidence of fixation

               -  Hydronephrosis on CT scan or intravenous pyelogram (IVP) or ureteric or bladder
                  invasion as documented by cystoscopy and cytology or biopsy, or invasion into
                  prostate

               -  Vaginal or uterine involvement

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  A surgical evaluation must confirm patient's ability to tolerate the proposed surgical
             procedure

          -  Patients must have a caloric intake > 1500 kilocalories/day (d)

          -  Within 4 weeks prior to registration, the patient's absolute neutrophil count (ANC)
             level must be >= 1,500/mm^3

          -  Within 4 weeks prior to registration, the patients platelet level must be >=
             100,000/mm^3

          -  Within 4 weeks prior to registration, serum creatinine must be < 1.5 X upper limit of
             normal (ULN); if serum creatinine > 1.5 x ULN, then creatinine clearance must be >= 50
             mL/mm

          -  Within 4 weeks prior to registration, serum bilirubin must be =< 1.5 X ULN

          -  Within 4 weeks prior to registration, alkaline phosphatase (alk phos) must be < 2 x
             ULN

          -  Within 4 weeks prior to registration, serum glutamic oxaloacetic transaminase (SGOT)
             must be < 2 x ULN

          -  Carcinoembryonic antigen (CEA) must be determined prior to initiation of therapy

          -  Within 4 weeks prior to registration, urine protein/creatinine (UPC) ratio must be <
             1; patients with a ratio of >= 1 must undergo a 24-hour urine collection which must be
             an adequate collection and must demonstrate < 1 gram (gm) of protein in order to
             participate

          -  Within 4 weeks prior to registration, albumin must be >= 2 gm/dl

          -  Absence of clinical evidence of high-grade (lumen diameter < 1 cm) large bowel
             obstruction, unless diverting colostomy has been performed

          -  Eligible patients of reproductive potential (both sexes) must agree to use an accepted
             and effective method of contraceptive during study therapy and for at least 6 months
             after the completion of bevacizumab

          -  Women must not be pregnant or breast-feeding; all females of childbearing potential
             must have a serum pregnancy test to rule out pregnancy within 2 weeks of registration

          -  Patients must have had no prior chemotherapy for rectal cancer or pelvic irradiation
             therapy

          -  Patients with prior malignancies, including pelvic cancer, are eligible if they have
             been disease free for > 5 years; patients with prior in situ carcinomas are eligible
             provided there was complete removal

          -  Patients must have no active inflammatory bowel disease or other serious medical
             illness or disease that might limit the patient's ability to receive protocol therapy

          -  Patients with a history of cerebrovascular accident (CVA)/transient ischemic attack
             (TIA) at any time, or myocardial infarction/unstable angina within 12 months of study
             entry are not eligible

          -  Patients with > grade 1 peripheral neuropathy are not eligible

          -  Patients must have urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC
             ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate
             collection and must demonstrate < 1 gm of protein in order to participate

          -  Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable
             regimen of anti-hypertensive therapy

          -  Patients with clinically significant peripheral vascular disease are not eligible

          -  Patients must not have any of the following:

               -  Unstable angina (within 12 months of study entry)

               -  New York Heart Association (NYHA) grade II or higher congestive heart failure

               -  Evidence of bleeding diathesis/coagulopathy

               -  Serious non-healing wound or bone fracture

          -  Patients with a history of the following within 28 days prior to registration are not
             eligible:

               -  Abdominal fistula

               -  Gastrointestinal perforation

               -  Intrabdominal abscess

          -  Patients with a history of the following within 28 days prior to day 0 (first
             treatment day) are not eligible:

               -  Major surgical procedure

               -  Open biopsy

               -  Significant traumatic injury

          -  Patients must not have core biopsy within 7 days prior to day 0 (first treatment day)

          -  Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are
             not eligible, unless the patient is on full-dose anticoagulants; if so, the following
             criteria must be met for enrollment:

               -  The subject must have an in-range INR (usually between 2 and 3), be on a stable
                  dose of warfarin or on a stable dose of low molecular weight heparin

               -  The subject must not have active bleeding or a pathological condition that is
                  associated with a high risk of bleeding