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SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
This study has been completed.
Study NCT00009919   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: July 23, 2008   History of Changes

February 2, 2001
July 23, 2008
November 2000
 
 
 
Complete list of historical versions of study NCT00009919 on ClinicalTrials.gov Archive Site
 
 
 
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Phase II Study of SU5416 (NSC 696819) for Interleukin-2 Progressing Patients With Metastatic Renal Cancer

RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2.

OBJECTIVES:

  • Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.
  • Determine the changes in tumor perfusion in patients treated with this regimen.
  • Determine the time to progression and survival in patients treated with this regimen.

OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 3-6 months.

Phase II
Interventional
Treatment
Kidney Cancer
Drug: semaxanib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma
  • Prior removal of primary tumors
  • Bidimensionally measurable disease

    • Bone-only disease is not considered measurable
  • Progressive disease following no more than 2 prior biologic therapy (e.g., interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) or fluorouracil-containing (single-agent or in combination therapy) regimens
  • No known history of CNS metastasis unless all of the following are true:

    • Previously treated
    • Neurologically stable
    • No requirement for IV steroids or anticonvulsants
    • No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI
  • Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGPT no greater than 2.5 times upper limit of normal
  • PT and PTT normal
  • Fibrinogen normal
  • D-Dimer assay normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • See Surgery
  • No active congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction or severe/unstable angina within the past 6 months
  • No uncontrolled hypertension
  • No uncompensated coronary artery disease on electrocardiogram or physical examination
  • No severe peripheral vascular disease
  • No deep vein or arterial thrombosis within the past 3 months

Pulmonary:

  • No pulmonary embolism within the past 3 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent serious infection
  • No overt psychosis, mental disability, or incompetence
  • No diabetes mellitus
  • No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No hypersensitivity or allergic reaction to paclitaxel

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No other concurrent anti-cancer biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No concurrent anti-cancer chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No sole indicator lesion within the previously irradiated port
  • No concurrent anti-cancer radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered
  • At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease
  • No concurrent surgery for cancer

Other:

  • No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009919
 
CDR0000068424, MDA-ID-99291, NCI-1290
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Arlene Siefker-Radtke, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
May 2002

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