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Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01024205
First received: December 1, 2009
Last updated: August 9, 2013
Last verified: July 2011
  Purpose

RATIONALE: Sunitinib malate 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 malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.


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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70% [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to radiological progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: August 2007
Study Completion Date: May 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine if neoadjuvant sunitinib malate can achieve a clinical benefit of 70% or more to the primary renal tumor prior to surgery and adjuvant sunitinib malate in patients with metastatic renal cancer.

Secondary

  • Determine the time to radiological progression in these patients.
  • Determine the overall survival of these patients.
  • Determine the proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate.
  • Determine the translational endpoints.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses. Approximately 2 weeks later, patients undergo a standard radical nephrectomy with lymph node dissection. Beginning at least 2 weeks after surgery, patients receive oral sunitinib malate on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed every 2 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Measurable metastatic disease on CT/MRI imaging
    • Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell disease
  • No prior therapy for renal cancer
  • Judged by the treating physician to have the potential to derive clinical benefit from this treatment

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support)
  • Platelet count ≥ 75 x 10^9/L
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) (except for patients with Gilbert disease)
  • Serum creatinine ≤ 2 times ULN
  • Serum transaminases < 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests and other study procedures
  • No congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 6 months, or ongoing severe or unstable arrhythmia requiring medication
  • No other severe acute or chronic medical or psychiatric condition, or abnormal laboratory results that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration or would make the patient inappropriate for entry into this study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 7 days since prior and no concurrent potent CYP3A inhibitors, including any of the following:

    • Ketoconazole
    • Itraconazole
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • Delavirdine
    • Indinavir
    • Saquinavir
    • Ritonavir
    • Atazanavir
    • Nelfinavir
  • At least 12 days since prior and no concurrent potent CYP3A inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • St. John's wort
    • Efavirenz
    • Tipranavir
  • Concurrent radiotherapy allowed provided sunitinib malate is stopped one day before and resumed one day after radiotherapy
  • Concurrent coumarin-derivative anticoagulants (e.g., warfarin) allowed (≤ 2 mg/day) for prophylaxis of thrombosis
  • No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide)
  • No other concurrent investigational drug or participation in another clinical trial (unless approved by the sponsor)
  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: NCT01024205

Locations
United Kingdom
Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
London, England, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
Investigators
Principal Investigator: Thomas Powles, MD, MRCP Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01024205     History of Changes
Other Study ID Numbers: OCTG-SuMR, CDR0000660317, EUDRACT-2006-004511-21, REDA-4911, MREC-07/Q0603/58, PFIZER-OCTG-SuMR
Study First Received: December 1, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on November 20, 2014