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SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: February 26, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006001
  Purpose

RATIONALE: SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic or locally recurrent colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: semaxanib
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the objective response rate and disease stabilization rates of patients with previously treated metastatic or locally recurrent colorectal cancer treated with SU5416. II. Determine the median and overall survival and time to progression in this patient population receiving this treatment. III. Determine the toxicity of SU5416 in these patients.

OUTLINE: This is a multicenter study. Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 weeks for 4 weeks.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum Progressive disease as defined by new or progressive radiologic lesions Measurable disease At least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and ascites are not considered measurable Lesion accessible for biopsy which is not within prior radiation port Known history of CNS metastasis allowed if patients have had treatment, are neurologically stable, and do not require oral or intravenous steroids or anticonvulsants, provided brain scan (CT or MRI) shows absence of active or residual disease If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within past 3 months Pulmonary: No pulmonary embolism within past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other significant uncontrolled underlying medical or psychiatric illness No serious active infections No concurrent second malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix unless completed therapy and considered to be at less than 30% risk of relapse No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 prior chemotherapy regimens for metastatic disease At least 4 weeks since prior chemotherapy No concurrent chemotherapy No other concurrent investigational antineoplastic drugs Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to only site of measurable disease At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since other prior investigational drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006001

Locations
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Division of Hematology/Oncology
Park Ridge, Illinois, United States, 60068
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068009, UCCRC-NCI-52, NCI-52
Study First Received: July 5, 2000
Last Updated: February 26, 2009
ClinicalTrials.gov Identifier: NCT00006001     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
SU 5416
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009