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Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors


I. To determine the maximally tolerated dose (MTD) of the combination of ixabepilone and
temsirolimus in patients with advanced solid tumors.

II. To describe toxicity profiles associated with the combination of ixabepilone and

III. To assess preliminary efficacy of the combination of ixabepilone and temsirolimus.

OUTLINE: This is a dose-escalation study.

Patients receive ixabepilone intravenously (IV) over 3 hours on day 1 and temsirolimus IV
over 30-60 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

After completion of study therapy, patients are followed up for 3 months.

Inclusion Criteria:

- Adult patients with histologically confirmed solid tumor malignancy that is
metastatic or unresectable and for which standard curative measures or other therapy
that provide survival benefit do not exist or are no longer effective; there are no
limitations on the number of prior therapeutic regimens

- Patients with non-measurable, but assessable, disease will be allowed

- Absolute neutrophil count >= 1500/mcL

- Hemoglobin >= 9.0 g/dL

- Platelets >= 100,000/mcL

- Total bilirubin < 1.5 mg/dL

- Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum
glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x
upper limit of normal (ULN) in the absence of hepatic metastasis; SGPT (ALT) =< 3 x
ULN or SGOT (AST) =< 5 x ULN in the presences of hepatic metastasis

- Creatinine =< 1.5 x ULN

- International normalized ratio (INR) =< 1.4 for patients not on warfarin (Coumadin)

- INR range of 2.0-3.0 for patients on therapeutic doses of warfarin (Coumadin®)

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2

- Ability to provide informed consent

- Willingness to return to a Mayo Clinic institution for follow up

- Life expectancy >= 84 days (12 weeks)

- Women of childbearing potential only: Negative serum pregnancy test done =< 7 days
prior to registration

Exclusion Criteria:

- Known standard therapy for the patient's disease that is potentially curative or
definitely capable of extending life expectancy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled diabetes or with hemoglobin A1c (HbA1C) > 8, or psychiatric
illness/social situations that would limit compliance with study requirements

- Any of the following prior therapies:

- Chemotherapy =< 28 days prior to registration

- Mitomycin C/nitrosoureas =< 42 days prior to registration

- Immunotherapy =< 28 days prior to registration

- Biologic therapy =< 28 days prior to registration

- Radiation therapy =< 28 days prior to registration

- Radiation to > 25% of bone marrow

- Failure to fully recover from acute, reversible effects of prior chemotherapy
regardless of interval since last treatment

- New York Heart Association classification III or IV

- Known central nervous system (CNS) metastases or seizure disorder; patients with
known brain metastases that have been successfully treated and stable for > 6 months
without requirement for corticosteroids and without seizure activity will be eligible

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (utilized for a non-Food and Drug Administration
[FDA]-approved indication and in the context of a research investigation)

- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Immunocompromised patients (other than that related to the use of corticosteroids)
including patients known to be HIV positive

- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm

- History of myocardial infarction =< 168 days (6 months), or congestive heart failure
requiring use of ongoing maintenance therapy for life-threatening ventricular

- >= Grade 2 sensory neuropathy

- >= Grade 2 hypertriglyceridemia

- >= Grade 2 hypercholesterolemia

- Patients on medication considered strong cytochrome P450 3A4 (CYP3A4) inducers
(efavirenz, nevirapine, carbamazepine, phenobarbital, phenytoin, pioglitazone,
rifabutin, rifampin, St. John's wort) or CYP3A4 inhibitors (indinavir, nelfinavir,
ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir,
telithromycin) unless the medication can be substituted with another agent

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients)

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Michael Menefee

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic in Florida Jacksonville, Florida  32224