Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors

NCT01072890

Last updated date
Study Location
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.

- Age ≥ 18 years old

- Zubrod (ECOG) Performance Status 0 - 2

- May have measurable or non-measurable disease.

- Adequate bone marrow and organ function as assessed by the following within 14 days prior to registration.

- Any number of prior chemotherapy regimens is allowed.

- Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.

- Pregnant or nursing women are ineligible because of the risk to the fetus. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent.

- Ability to swallow and retain oral medications.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with an mTOR inhibitor or pazopanib.


- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina (anginal symptoms at rest) or new onset angina (began within the last
3 months) or myocardial infarction within the past 6 months.


- Symptomatic or uncontrolled brain metastasis.


- Must have a EKG within 14 days of registration and a QTc of < 480 msec. If the initial
QTc is > 480 msec, two subsequent EKGs should be obtained within 5 minutes.


- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.


- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C due to
the immunosuppressive effects of temsirolimus.


- Active clinically serious infection > CTCAE Grade 2.


- Fasting cholesterol > 350mg/dL and fasting triglycerides > 400mg/dL


- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.


- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of
study drug.


- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of
study drug.


- Serious non-healing wound, ulcer, or bone fracture.


- Evidence or history of bleeding diathesis or coagulopathy. Therapeutic anticoagulation
with warfarin, heparin or low molecular weight heparin is not allowed. Patients may
not have had an arterial thrombotic event within the past 6 months.


- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
dose of study drug.


- May not take known strong CYP3A4 inducers such as rifampin or St. John's wort or
strong CYP3A4 inhibitors such as ketoconazole, diltiazem, or verapamil.


- Known or suspected allergy to temsirolimus or pazopanib, any similar agents such as
the rapamycin analog sirolimus, or any agent given in the course of this trial.


- Any condition that impairs patient's ability to swallow whole pills.

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors
Official Title  ICMJE Phase I Study of the Combination of Temsirolimus (CCI-779) and Pazopanib (GW786034) in Patients With Advanced Solid Tumors
Brief Summary The purpose of this study is to test the safety of temsirolimus and pazopanib at different doses. Patients who have an advanced cancer that is not felt to benefit from standard treatment or are no longer responding to other treatment will be asked to take part in this study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mammalian target of rapamycin (mTOR) and vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in treating patients with advanced solid tumors.
Detailed Description Despite encouraging clinical activity reported with single-agent VEGF inhibitors, mTOR inhibitors, and other novel agents, patients rarely achieve complete disease response and ultimately undergo disease progression. The limited efficacy of single-target inhibition may be due to numerous, overlapping signaling pathways involved in Renal Cell Carcinoma proliferation and growth. A strategy of multi-target "vertical inhibition" of the overlapping aberrant VEGF and mTOR pathways by combination therapy may translate to enhanced efficacy over each single agent alone. We hypothesize that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mTOR and VEGFR signaling pathways will be effective in treating patients with advanced solid tumors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: Temsirolimus, Pazopanib
Patients will be treated on an outpatient basis with both temsirolimus and pazopanib. All patients will receive temsirolimus intravenously (IV) weekly days 1, 8, 15, and 22. Patients will receive oral pazopanib on a daily basis starting day 1. Treatment will be administered on 28 day cycles. Patients will be in this study for a minimum of 8 weeks or 2 cycles.
Other Names:
  • Torisel
  • Votrient
Study Arms  ICMJE Experimental: Temsirolimus and Pazopanib
Intervention: Drug: Temsirolimus, Pazopanib
Publications * Semrad TJ, Eddings C, Dutia MP, Christensen S, Lara PN Jr. Phase I study of the combination of temsirolimus and pazopanib in advanced solid tumors. Anticancer Drugs. 2013 Jul;24(6):636-40. doi: 10.1097/CAD.0b013e3283618b7b.

*   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: March 26, 2012)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2010)
30
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
  • Age ? 18 years old
  • Zubrod (ECOG) Performance Status 0 - 2
  • May have measurable or non-measurable disease.
  • Adequate bone marrow and organ function as assessed by the following within 14 days prior to registration.
  • Any number of prior chemotherapy regimens is allowed.
  • Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.
  • Pregnant or nursing women are ineligible because of the risk to the fetus. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent.
  • Ability to swallow and retain oral medications.

Exclusion Criteria:

  • Prior treatment with an mTOR inhibitor or pazopanib.
  • Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Symptomatic or uncontrolled brain metastasis.
  • Must have a EKG within 14 days of registration and a QTc of < 480 msec. If the initial QTc is > 480 msec, two subsequent EKGs should be obtained within 5 minutes.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C due to the immunosuppressive effects of temsirolimus.
  • Active clinically serious infection > CTCAE Grade 2.
  • Fasting cholesterol > 350mg/dL and fasting triglycerides > 400mg/dL
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event ? CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event ? CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy. Therapeutic anticoagulation with warfarin, heparin or low molecular weight heparin is not allowed. Patients may not have had an arterial thrombotic event within the past 6 months.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.
  • May not take known strong CYP3A4 inducers such as rifampin or St. John's wort or strong CYP3A4 inhibitors such as ketoconazole, diltiazem, or verapamil.
  • Known or suspected allergy to temsirolimus or pazopanib, any similar agents such as the rapamycin analog sirolimus, or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
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 NCT01072890
Other Study ID Numbers  ICMJE 200917514
UCDCC#222 ( Other Identifier: University of California Davis )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • GlaxoSmithKline
  • Pfizer
Investigators  ICMJE
Principal Investigator:Primo N Lara, MDUniversity of California, Davis
PRS Account University of California, Davis
Verification Date March 2012

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