Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00462501
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • fluorouracil — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG
  • conventional surgery — PROCEDURE
  • radiation therapy — RADIATION

Study Details

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 cancer

Key Dates

First listed
Apr 19, 2007
Start date
Mar 31, 2007
Status verified
Dec 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy and Bevacizumab With or Without Radiation
    FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.

Primary Outcome Measure

Complete Pathologic Response [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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