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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00626509
First received: February 28, 2008
Last updated: August 9, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: sunitinib malate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: February 2008
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626509

Locations
Italy
Ospedale Sacro Cuore Recruiting
Negrar, Italy, 37024
Contact: Contact Person    39-045-601-3912      
Sponsors and Collaborators
Gruppo Italiano Carcinoma Renale
Investigators
Principal Investigator: Marco Venturini, MD Ospedale Sacro Cuore
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00626509     History of Changes
Other Study ID Numbers: GICR-GIR-1, CDR0000588423, EUDRACT-2007-005977-67
Study First Received: February 28, 2008
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014