SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006001
• Other study ID #: NCI-2012-02345
• Secondary ID: UCCRC-NCI-52NCI-
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: May 31, 2013
• Start date: August 2000
• Est. completion date: August 2009

Study information

• Verified date: February 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic or locally recurrent colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: August 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• WBC at least 3,000/mm3

• Platelet count at least 75,000/mm3

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

• 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

• No pulmonary embolism within past 3 months

• 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:

• 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

• No prior radiotherapy to only site of measurable disease

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

• At least 30 days since other prior investigational drugs

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• semaxanib

Locations

Country	Name	City	State
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Division of Hematology/Oncology	Park Ridge	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,