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

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
sunitinib malate
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
Gruppo Italiano Carcinoma Renale
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Sacro CuoreRecruiting

Outcomes

Primary Outcome Measures

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

Time to progression
Duration of response
Overall survival

Full Information

First Posted
February 28, 2008
Last Updated
August 9, 2013
Sponsor
Gruppo Italiano Carcinoma Renale
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1. Study Identification

Unique Protocol Identification Number
NCT00626509
Brief Title
Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer
Official Title
Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Carcinoma Renale

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Title
Adverse events as assessed by NCI CTCAE v3.0
Secondary Outcome Measure Information:
Title
Time to progression
Title
Duration of response
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Venturini, MD
Organizational Affiliation
Ospedale Sacro Cuore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Sacro Cuore
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-045-601-3912

12. IPD Sharing Statement

Learn more about this trial

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

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