Study of Axitinib and Temsirolimus in Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Kauh, Emory University
ClinicalTrials.gov Identifier:
NCT01529138
First received: November 14, 2011
Last updated: May 17, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 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 RECIST(Response Evaluation Criteria in Solid Tumors)criteria for evaluation. [ Time Frame: Approximately re-evaluated every 8 weeks ] [ Designated as safety issue: Yes ]

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

    Partial Response:At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease: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.



Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus
is an ester of the macrocyclic immunosuppressive agent sirolimus
Drug: Temsirolimus
Combination treatment with temsirolimus and axitinib
Experimental: Axitinib
An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3.
Drug: Axitinib
Combination treatment with temsirolimus and axitinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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)
    • AST and 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 < 1000mg for patient enrollment.
    • Fasting serum cholesterol ≤ 350mg/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. Prexisting 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: MI, uncontrolled angina, CABG, or symptomatic 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 CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529138

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: John Kauh, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: John Kauh, PI, Emory University
ClinicalTrials.gov Identifier: NCT01529138     History of Changes
Other Study ID Numbers: WCI1939-10
Study First Received: November 14, 2011
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Cancer

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014