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VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

2014-08-27 03:41:15 | BioPortfolio

Summary

RATIONALE: VEGF Trap may stop the growth of colorectal cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with previously treated metastatic colorectal cancer.

Description

OBJECTIVES:

Primary

- Determine the response rate (complete and partial) in patients with previously treated metastatic colorectal cancer treated with VEGF Trap.

- Determine the incidence of disease stabilization, in terms of 4-month progression-free survival, in patients treated with this drug.

Secondary

- Determine the median survival time of patients treated with this drug.

- Determine the 1-year survival rate and stable disease rate in patients treated with this drug.

- Determine the response or stable disease duration in patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Determine the time to disease progression in patients treated with this drug.

- Determine if changes in free VEGF Trap levels correlate with response or toxicity.

OUTLINE: This is a multicenter, open-label study. Patients are stratified according to prior bevacizumab treatment (yes vs no).

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at the beginning of each course and at 60 days after completion of study treatment. Samples are analyzed by immunoenzyme techniques to determine the pharmacokinetics of VEGF Trap.

After completion of study treatment, patients are followed at 30 and 60 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

aflibercept, immunoenzyme technique, pharmacological study

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263-0001

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:15-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.

A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

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