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

Stage IV Renal Cell Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00009919
• Other study ID #: NCI-2012-02373
• Secondary ID: ID99-291N01CM170
• Status: Terminated
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: January 22, 2013
• Start date: December 2000

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• semaxanib
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of progression-free events	Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.	6 months	No
Primary	Objective response rate	Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.	Up to 3 years	No
Secondary	Survival	Analyzed using Kaplan Meier curves and Cox proportional hazards models.	Up to 3 years	No
Secondary	Time to disease progression	Analyzed using Kaplan Meier curves and Cox proportional hazards.	Up to 3 years	No
Secondary	Time to treatment failure	Analyzed using Kaplan Meier curves and Cox proportional hazards.	Up to 3 years	No
Secondary	Duration of response	Analyzed using Kaplan Meier curves and Cox proportional hazards.	Up to 3 years	No