Overview
Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer
Status:
Completed
Completed
Trial end date:
2014-02-01
2014-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy, such as 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of rectal cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and bevacizumab together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without radiation therapy works in treating patients with locally advanced rectal cancerPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborators:
Genentech, Inc.
National Cancer Institute (NCI)Treatments:
Bevacizumab
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
DISEASE CHARACTERISTICS:- Histologically or pathologically confirmed adenocarcinoma of the rectum
- Clinical stage T1, N1; T2, N1; T3, N0; or T3, N1 by endorectal ultrasonography
(ERUS)
- No bulky N2 disease by either ERUS or MRI
- No primary fixed or unresectable (clinical stage T4) rectal cancer or
recurrent colorectal cancer limited to the pelvis
- Primary unresectable rectal cancer is defined as a primary rectal tumor
which on the basis of either physical exam, ERUS or pelvic MRI is
deemed to be adherent or fixed to adjacent pelvic structures
- Must be a candidate for all of the following:
- Neoadjuvant chemoradiotherapy
- Systemic therapy with fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX), and
bevacizumab
- Complete surgical resection via low anterior resection prior to administration of
any therapy
- No low-lying tumors deemed to require an abdominal perineal resection
- No large or bulky tumors that require a diverting colostomy or placement of an
endorectal stent prior to treatment initiation
- No clinical evidence of metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count > 150,000/mm^3
- Hemoglobin > 8.0 g/dL
- Creatinine ≤ 1.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after
completion of study therapy
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
- No arterial thrombotic event within the past 6 months, including stable or unstable
angina, myocardial infarction (MI), or cerebral vascular accident (CVA)
- Deep venous thrombosis, pulmonary embolus, MI, CVA, atrial fibrillation, or any
other conditions occurring more than 6 months ago allowed provided patient is on
stable doses of anticoagulant therapy
- No other medical or psychiatric condition or disease that would preclude study therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or surgery for rectal cancer
- No prior pelvic radiotherapy
- No other concurrent experimental therapy, including any of the following:
- Chemotherapy
- Radiotherapy
- Hormonal therapy
- Antibody therapy
- Immunotherapy
- Gene therapy
- Vaccine therapy
- Angiogenesis inhibitors
- Matrix metalloprotease inhibitors
- Thalidomide
- Anti-vascular endothelial growth factor/Flk-1 monoclonal antibody
- Any other experimental drugs