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

Phase 2

Terminated

• Conditions: Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer
• Interventions: Drug: semaxanib

• Registration Number: NCT00009919
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-02-02
• Primary Completion: 2003-06
• Study First Submitted QC: 2003-12-31
• Study First Posted: 2004-01-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (semaxanib)	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.

Primary Outcome Measures

Name	Time	Method
Rate of progression-free events	6 months	Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Objective response rate	Up to 3 years	Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.

Secondary Outcome Measures

Name	Time	Method
Survival	Up to 3 years	Analyzed using Kaplan Meier curves and Cox proportional hazards models.
Time to disease progression	Up to 3 years	Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time to treatment failure	Up to 3 years	Analyzed using Kaplan Meier curves and Cox proportional hazards.
Duration of response	Up to 3 years	Analyzed using Kaplan Meier curves and Cox proportional hazards.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States