SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

NCT00006001 | Terminated Phase 2

• 4 other identifiers: NCI-2012-02345UCCRC-NCI-52NCI-52CDR0000068009
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Colorectal Cancer

Keywords

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 Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

semaxanib DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (10)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Division of Hematology/Oncology

Park Ridge, Illinois, 60068, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hedy L. Kindler, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: May 26, 2004
• Study Start: August 1, 2000
• Primary Completion: February 1, 2007
• Study Completion: August 1, 2009
• Last Updated: June 3, 2013

Record last verified: 2009-02

Locations

US (10)