Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer

August 9, 2013 updated by: Gruppo Italiano Carcinoma Renale

Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.

PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To compare the activity of sunitinib malate when administered before vs after cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal cell carcinoma.
  • To compare the safety of these regimens in these patients.

Secondary

  • To compare the time to progression in patients treated with these regimens.
  • To compare the duration of response in patients treated with these regimens.
  • To compare the overall survival of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment beyond 1 year at the discretion of the investigator.
  • Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant sunitinib malate as in arm I.

After completion of study therapy, patients are followed every 2 months for up to 1 year.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Negrar, Italy, 37024
        • Recruiting
        • Ospedale Sacro Cuore
        • Contact:
          • Contact Person
          • Phone Number: 39-045-601-3912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Proven metastatic renal cell carcinoma
  • Measurable disease (according to RECIST criteria)

  • Eligible for cytoreductive nephrectomy

    • Primary tumor is considered amenable to surgical extirpation by the attending surgeon
    • Thrombosis of the inferior vena cava below the epathic veins allowed
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Adequate hematology and coagulation
  • Amylase and lipase normal
  • Adequate hepatic, renal, and cardiac function
  • Not pregnant
  • Negative pregnancy test
  • No uncontrolled hypertension and/or clinically significant cardiovascular events or disease within the past 12 months
  • No other cancer within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • No prior early nephrectomy due to clinical condition
  • No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other biological response modifiers)

  • More than 12 days since prior potent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • St. John's wort
    • Efavirenz
    • Tipranavir

  • More than 7 days since prior potent CYP3A4 inhibitors, including any of the following:

    • Ketoconazole
    • Itraconazole
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • Delavirdine
    • Indinavir
    • Saquinavir
    • Ritonavir
    • Atazanavir
    • Nelfinavir
  • No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
  • No concurrent participation in any other treatment clinical trial
  • No concurrent palliative radiotherapy or surgery

  • No concurrent drugs with proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • Concurrent bisphosphonate therapy for metastatic bone disease allowed provided therapy was initiated at least 4 weeks prior to the first dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Adverse events as assessed by NCI CTCAE v3.0

Secondary Outcome Measures

Outcome Measure
Time to progression
Overall survival
Duration of response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Carcinoma Renale

Investigators

  • Principal Investigator: Marco Venturini, MD, Ospedale Sacro Cuore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICR-GIR-1
  • CDR0000588423 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2007-005977-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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