Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer

Completed · Phase 2

Conditions studied: Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v7, Stage III Rectal Cancer AJCC v7

In brief

This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

Key facts

Study ID

NCT00321685

Run by

National Cancer Institute (NCI)

People needed

57

Starts

2006-07-25

Expected to finish

2019-02-11

Last updated by the study team

2019-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• MacNeal Hospital and Cancer Center — Berwyn, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Jesse Brown Veterans Affairs Medical Center — Chicago, Illinois, United States
• Mercy Hospital and Medical Center — Chicago, Illinois, United States
• Swedish Covenant Hospital — Chicago, Illinois, United States
• Presence Saint Joseph Hospital-Chicago — Chicago, Illinois, United States
• Saint Anthony Memorial Hospital — Effingham, Illinois, United States
• Hematology Oncology Associates of Illinois-Highland Park — Highland Park, Illinois, United States
• Hinsdale Hematology Oncology Associates Incorporated — Hinsdale, Illinois, United States
• Midwest Center for Hematology Oncology — Joliet, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• NorthShore Hematology Oncology-Libertyville — Libertyville, Illinois, United States
• Garneau, Stewart C MD (UIA Investigator) — Moline, Illinois, United States
• Porubcin, Michael MD (UIA Investigator) — Moline, Illinois, United States
• Sharis, Christine M MD (UIA Investigator) — Moline, Illinois, United States
• Spector, David MD (UIA Investigator) — Moline, Illinois, United States
• Stoffel, Thomas J MD (UIA Investigator) — Moline, Illinois, United States
• Trinity Medical Center — Moline, Illinois, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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