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Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583063
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : June 12, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Last Update Posted Date June 12, 2013
Study Start Date  ICMJE October 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Pharmacokinetic interactions [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Toxicity of the combined drug regimen [ Time Frame: 4 weeks ]
  • Response to drug regimen [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers
Official Title  ICMJE A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors
Brief Summary Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: sunitinib
    25 mg daily (oral dosing)
    Other Name: Sutent
  • Drug: rapamycin
    4 mg daily (oral dosing)
    Other Name: Rapamune
Study Arms  ICMJE
  • Experimental: A
    Sunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
    Interventions:
    • Drug: sunitinib
    • Drug: rapamycin
  • Experimental: B
    Rapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
    Interventions:
    • Drug: sunitinib
    • Drug: rapamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2008)
23
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
16
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic or unresectable cancer for which standard treatments do not exist or are no longer effective or cancers where evidence of efficacy of single agent sunitinib or single agent mTOR inhibitor has been demonstrated
  • Measurable or non-measurable disease.
  • No prior treatments for 4 weeks before starting study
  • No ongoing toxicities from previous treatments
  • 18 years or older
  • Performance status 2 or better
  • Life expectancy of at least 3 months.
  • Normal organ and marrow function as defined below:

    • No transfusions of packed red blood cells within 1 week of starting treatment. A hemoglobin of 9.0 g/dL or greater is recommended. Patients should not be transfused for protocol participation.
    • Leukocytes greater than or equal to 3,000/μL
    • Absolute neutrophil count greater than or equal to 1,500/μL
    • Platelets greater than or equal to 100,000/μL
    • Total bilirubin less than or equal to 1.5 x ULN
    • AST and ALT less than or equal to 2.5x ULN (less than or equal to 5x ULN if liver function abnormalities are due to underlying disease)
    • Creatinine within normal institutional limits OR
    • Creatinine clearance > 60 mL/min/1.73 m2
    • PT or INR within normal institutional limits
    • Serum calcium within normal institutional limits
  • QTc < 500 msec.
  • Patients with prior anthracycline exposure or that have received central thoracic radiation must have NYHA class I cardiac function
  • Must agree to use adequate birth control
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior treatments within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study or those who have not recovered from adverse events due prior treatments
  • Current treatment with other investigational agents.
  • Prior therapy with a VEGFR or mTOR inhibitor
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin or sunitinib.
  • QTc prolongation (QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with any of the following conditions are excluded:

    • Serious or non-healing wound, ulcer, or bone fracture.
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
    • Known active infection
    • Major surgery or radiation therapy within 4 weeks of starting the study treatment.
    • NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
    • History of CVA or transient ischemic attack within 12 months prior to study entry.
    • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
    • History of pulmonary embolism within the past 12 months.
    • Class III or IV heart failure as defined by the NYHA functional classification system
    • Ongoing cardiac dysrhythmias
    • Poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
    • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    • History of interstitial lung disease
  • Patients with severe immunodeficient states (as judged by the treating physician)
  • Pregnancy or breastfeeding.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for interactions with the study drugs
  • Use of certain medications (as determined by the investigator)
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk or interfere with the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583063
Other Study ID Numbers  ICMJE 15328B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Ezra Cohen, MD University of Chicago
PRS Account University of Chicago
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP