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SU5416 in Treating Patients With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006014
Recruitment Status : Completed
First Posted : February 26, 2004
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE February 26, 2004
Last Update Posted Date June 3, 2013
Study Start Date  ICMJE August 2000
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SU5416 in Treating Patients With Malignant Mesothelioma
Official Title  ICMJE A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
Brief Summary Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.
Detailed Description

OBJECTIVES:

I. Determine the objective response rate, median and overall survival, and time to progression in patients with unresectable malignant mesothelioma treated with SU5416.

II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels, and tumor perfusion measured by MRI in these patients.

III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Mesothelioma
Intervention  ICMJE Drug: semaxanib
Study Arms  ICMJE Experimental: Arm I
Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: semaxanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March¬†1,¬†2013)
45
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) that is not amenable to surgery or radiotherapy
  • Measurable disease
  • At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
  • Pleural effusions and ascites are not considered measurable lesions
  • Only site of measurable disease must not be located within prior radiotherapy port
  • Lesion must be accessible for biopsy
  • History of previously treated CNS metastasis allowed if:

    • Neurologically stable
    • No requirement for IV or oral steroids or IV anticonvulsants
    • No active or residual disease by brain CT or MRI scan
  • Patients with neurologic signs or symptoms suggestive of CNS metastasis must have a negative brain CT or MRI scan

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
  • SGOT and SGPT 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 on electrocardiogram or physical examination
  • No history of myocardial infarction or severe/unstable angina within the past 6 months
  • No severe peripheral vascular disease associated with diabetes mellitus
  • No deep vein or arterial thrombosis within the past 3 months
  • No pulmonary embolism within the past 3 months
  • No significant uncontrolled underlying medical or psychiatric illness
  • No serious active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Patients are not considered to have active malignancy if they have completed therapy and are 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 1 prior systemic chemotherapy regimen
  • At least 4 weeks since prior systemic chemotherapy and recovered
  • Prior intrapleural cytotoxic agents (including bleomycin) allowed
  • No concurrent chemotherapy
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • At least 30 days since prior investigational drug and recovered
  • No concurrent investigational drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006014
Other Study ID Numbers  ICMJE NCI-2012-02351
UCCRC-10409
UCCRC-NCI-44
NCI-44
CDR0000068023 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Cancer Institute (NCI)
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Cancer Institute (NCI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hedy L. Kindler, MD University of Chicago
PRS Account National Cancer Institute (NCI)
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP