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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00321685 |
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with radiation therapy and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer.
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: bevacizumab Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Bevacizumab Fluorouracil Oxaliplatin Calcium gluconate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer |
Estimated Enrollment: | 58 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to primary tumor size (T3 vs T4).
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum
Must have primary T3 or T4 tumor
Transmural penetration of tumor through the muscularis propria by CT scan plus endorectal ultrasound or MRI
Tumors that are clinically fixed, clinical stage T4, N0-2, M0 are eligible if it is believed that the tumors are potentially resectable after chemoradiotherapy, based on the following:
Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum
Nonmetastatic disease
Resectable disease, defined as completely resectable disease with negative margins based on routine examination of the non-anesthetized patient
PATIENT CHARACTERISTICS:
Urine protein:creatinine ratio < 1
INR ≤ 1.5 unless patient is on full-dose anticoagulants and the following criteria is met:
PRIOR CONCURRENT THERAPY:
Eastern Cooperative Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Jerome C. Landry, MD | Emory University |
Investigator: | Steven J. Cohen, MD | Fox Chase Cancer Center |
Investigator: | Charles A. Staley, MD | Emory University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000471148, ECOG-E3204 |
First Received: | May 2, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00321685 |
Health Authority: | United States: Food and Drug Administration |
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