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SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
This study has been completed.
First Received: February 2, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009919
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: semaxanib
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of SU5416 (NSC 696819) for Interleukin-2 Progressing Patients With Metastatic Renal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009919

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Arlene Siefker-Radtke, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068424, MDA-ID-99291, NCI-1290
Study First Received: February 2, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00009919     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
SU 5416
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Interleukin-2
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009