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AzTrials

Colorectal CancerPhase 2NCT00006001

SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

A Phase 2 study testing semaxanib in people with Colorectal Cancer, run by National Cancer Institute (NCI) at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
semaxanib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
10 sitesUnited States
Study dates
Aug 2000to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Cancer Care Specialists of Central Illinois, S.C.

    Decatur, Illinois, 62526

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46885-5099

  • Division of Hematology/Oncology

    Park Ridge, Illinois, 60068

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

    Peoria, Illinois, 61602

  • Michiana Hematology/Oncology P.C.

    South Bend, Indiana, 46617

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62701

Other trials in United States

About this study

Official title: 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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
semaxanib
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
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaxanibDrug

Study groups in NCT00006001
Study groupRoleWhat they receive
Arm IExperimentalPatient 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.
Receives: Drug: semaxanib

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2004 (estimated)
  2. Study startAug 2000
  3. Primary completionFeb 2007
  4. Study completionAug 2009

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006001
Sponsor's protocol ID
NCI-2012-02345
Other IDs
UCCRC-NCI-52, NCI-52, CDR0000068009
Status last verified
Feb 2009
First submitted
5 Jul 2000
Last updated
3 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaxanib in people with Colorectal Cancer, run by National Cancer Institute (NCI) at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.

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