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

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

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

Study Overview

• Status: Terminated
• Conditions: Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer
• Intervention / Treatment: Drug: semaxanib

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: semaxanib; Given IV; Other Names: SU5416; semoxind; Sugen 5416

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: February 2, 2001
• First Submitted That Met QC Criteria: December 31, 2003
• First Posted (Estimate): January 1, 2004

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Semaxinib
• Other Study ID Numbers: NCI-2012-02373; N01CM17003 (U.S. NIH Grant/Contract); ID99-291; CDR0000068424 (Registry Identifier: PDQ (Physician Data Query))