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SU5416 in Treating Patients With Malignant Mesothelioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006014
First received: July 5, 2000
Last updated: May 31, 2013
Last verified: February 2009

July 5, 2000
May 31, 2013
August 2000
February 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00006014 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SU5416 in Treating Patients With Malignant Mesothelioma
A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Mesothelioma
Drug: semaxanib
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2009
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006014
NCI-2012-02351, UCCRC-10409, UCCRC-NCI-44, NCI-44, CDR0000068023
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Hedy L. Kindler, MD University of Chicago
National Cancer Institute (NCI)
February 2009

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