SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: semaxanib

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; 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.	Drug: semaxanib

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: May 25, 2004
• First Posted (Estimate): May 26, 2004

Study Record Updates

• Last Update Posted (Estimate): June 3, 2013
• Last Update Submitted That Met QC Criteria: May 31, 2013
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage III rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Semaxinib
• Other Study ID Numbers: NCI-2012-02345; UCCRC-NCI-52; NCI-52; CDR0000068009 (Registry Identifier: PDQ (Physician Data Query))