ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers

This study has been completed.

Sponsors and Collaborators: University of Chicago
Pfizer
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00583063
  Purpose

Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.


Condition Intervention Phase
Solid Tumors
Drug: sunitinib
Drug: rapamycin
Phase 0

MedlinePlus related topics:   Cancer   

Drug Information available for:   Sunitinib    Sunitinib malate    Sirolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:   A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pharmacokinetic interactions [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity of the combined drug regimen [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Response to drug regimen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:   23
Study Start Date:   October 2007
Study Completion Date:   April 2008
Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
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.
Drug: sunitinib
25 mg daily (oral dosing)
Drug: rapamycin
4 mg daily (oral dosing)
B: Experimental
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.
Drug: sunitinib
25 mg daily (oral dosing)
Drug: rapamycin
4 mg daily (oral dosing)

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

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583063

Locations
United States, Illinois
University of Chicago    
      Chicago, Illinois, United States, 60637

Sponsors and Collaborators
University of Chicago
Pfizer

Investigators
Principal Investigator:     Ezra Cohen, MD     University of Chicago    
  More Information


Responsible Party:   University of Chicago ( Ezra Cohen, MD )
Study ID Numbers:   15328B
First Received:   December 20, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00583063
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Sirolimus
Clotrimazole
Sunitinib
Miconazole
Tioconazole

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 31, 2008




Links to all studies - primarily for crawlers