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Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens

Phase 2
16 Years
Not Enrolling
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

Thank you

Trial Information

Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens


I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal
cancer failing prior biologic therapy or fluorouracil-containing regimens.

II. Determine the changes in tumor perfusion in patients treated with this regimen.

III. Determine the time to progression and survival in patients treated with this regimen.


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.

Inclusion Criteria:

- 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)
orfluorouracil-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

- Performance status - Zubrod 0-2

- At least 12 weeks

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- 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

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- 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

- No pulmonary embolism within the past 3 months

- 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

- See Disease Characteristics

- No other concurrent anti-cancer biologic therapy

- See Disease Characteristics

- No concurrent anti-cancer chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

- No sole indicator lesion within the previously irradiated port

- No concurrent anti-cancer radiotherapy

- 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

- No concurrent surgery for cancer

- No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days
prior to and after study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of progression-free events

Outcome Description:

Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Arlene Siefker-Radtke

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell



M D Anderson Cancer Center Houston, Texas  77030