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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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


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

Inclusion Criteria


- 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

- If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan


- 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


- 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

Type of Study:


Study Design:

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

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

August 2000

Completion Date:

August 2009

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms



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