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Study of Axitinib and Temsirolimus in Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529138
First Posted: February 8, 2012
Last Update Posted: April 13, 2015
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bradley Carthon MD, PhD, Emory University
  Purpose

This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment.

The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer.

Temsirolimus is commercially available and approved for treatment of some types of kidney cancer.

Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States.

The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.


Condition Intervention Phase
Cancer Drug: Axitinib Drug: Temsirolimus Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Axitinib and Temsirolimus in Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bradley Carthon MD, PhD, Emory University:

Primary Outcome Measures:
  • Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation. [ Time Frame: Approximately re-evaluated every 8 weeks ]

    Complete Response: Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions).

    Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.



Enrollment: 13
Study Start Date: October 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus
An ester of the macrocyclic immunosuppressive agent sirolimus.
Drug: Temsirolimus
Combination treatment with temsirolimus and axitinib
Other Names:
  • Torisel
  • CCI-779
Experimental: Axitinib
An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3.
Drug: Axitinib
Combination treatment with temsirolimus and axitinib
Other Names:
  • Inlyta
  • AG013736

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria/Exclusion Criteria:

  • Patients must have histologically confirmed non-hematologic malignancy for which standard curative or palliative measures do not exist or are no longer effective
  • Patients with hepatocellular carcinoma do not need histologic confirmation of malignancy if the following criteria were met at diagnosis:

    • Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of CT/MRI
    • Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of CT/MRI or serum alpha-feto protein ≥ 200 ng/mL
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Marrow and Organ function requirements:

    • Absolute Neutrophil Count ≥ 1000/mm³
    • Platelets ≥ 75,000/mm³
    • Hemoglobin ≥ 9.0 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present or patient has diagnosis of hepatocellular carcinoma or cholangiocarcinoma)
    • Creatinine ≤ 1.5 x ULN
    • Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0 If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
    • Fasting serum cholesterol ≤ 350 mg/dL
    • Triglycerides ≤1.5 x ULN
  • Life expectancy ≥ 12 weeks
  • At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab containing regimens), radiotherapy, or surgical procedure with resolution of all treatment related toxicity
  • No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90 measured 1 hour apart. Preexisting hypertension controlled with medication is allowed
  • No gastrointestinal disorders including active peptic ulcer disease (within 6 months); active bleeding unrelated to malignancy; or melena, hematemesis, or hematochezia in the past 3 months without endoscopically-proven resolution
  • No cardiovascular history within 12 months including: myocardial infarction (MI), uncontrolled angina, coronary artery bypass graft (CABG), or symptomatic congestive heart failure (CHF)
  • Women of child bearing potential must have negative pregnancy test
  • Willingness and ability to comply with scheduled visits
  • Able to ingest oral medications
  • No concurrent use or anticipated need for potent cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529138


Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Pfizer
Investigators
Principal Investigator: Bradley Carthon, MD, PhD Emory University Winship Cancer Institute
  More Information

Responsible Party: Bradley Carthon MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01529138     History of Changes
Other Study ID Numbers: IRB00048705
WCI1939-10 ( Other Identifier: Other )
First Submitted: November 14, 2011
First Posted: February 8, 2012
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Bradley Carthon MD, PhD, Emory University:
Cancer

Additional relevant MeSH terms:
Everolimus
Sirolimus
Axitinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action