Study of Axitinib and Temsirolimus in Solid Tumors

NCT01529138 | Completed Phase 1 DMC

• 2 other identifiers: IRB00048705WCI1939-10
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Approximately re-evaluated every 8 weeks

Study Arms (2)

Temsirolimus

EXPERIMENTAL

An ester of the macrocyclic immunosuppressive agent sirolimus.

Drug: Temsirolimus

Axitinib

EXPERIMENTAL

An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3.

Drug: Axitinib

Interventions

Axitinib DRUG

Combination treatment with temsirolimus and axitinib

Also known as: Inlyta, AG013736

Axitinib

Temsirolimus DRUG

Combination treatment with temsirolimus and axitinib

Also known as: Torisel, CCI-779

Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Pfizer: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Axitinib; temsirolimus

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bradley Carthon, MD, PhD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: February 8, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

US (1)