SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment

NCT ID: NCT00009919

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31

Brief Summary

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

Detailed Description

OBJECTIVES:

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.

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.

Conditions

Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (semaxanib)

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 CR receive an additional 6 months of therapy after achieving CR.

Group Type: EXPERIMENTAL

semaxanib

Intervention Type: DRUG

Given IV

Interventions

semaxanib

Given IV

Intervention Type: DRUG

Other Intervention Names

semoxind; SU5416; Sugen 5416

Eligibility Criteria

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 disease
• No concurrent surgery for cancer
• No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arlene Siefker-Radtke

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

ID99-291

Identifier Type: -

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068424

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02373

Identifier Type: -

Identifier Source: org_study_id