Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

NCT01375829 | Active Not Recruiting Phase 1

• 9 other identifiers: NCI-2012-02907NCI-2012-01136CDR0000702380NCI-2011-01140MC10138814P30CA015083U01CA069912UM1CA186686
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in treating patients with solid tumors that have spread from the primary site to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with temsirolimus may kill more tumor cells.

Conditions

Adult Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• MTD of the combination of ixabepilone and temsirolimus, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients)

  21 days

Secondary Outcomes (8)

• Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Up to 3 months

• Incidence of overall toxicity graded according to Common Toxicity Criteria standard grading

  Up to 3 months

• Best response, defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence

  Up to 3 months

• Time until any treatment related toxicity

  Up to 3 months

• Time until treatment related grade 3+ toxicity

  Up to 3 months

Study Arms (1)

Treatment (ixabepilone, temsirolimus)

EXPERIMENTAL

Patients receive ixabepilone IV over 3 hours on day 1 and temsirolimus IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Ixabepilone; Other: Pharmacological Study; Drug: Temsirolimus

Interventions

Ixabepilone DRUG

Given IV

Also known as: (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550, BMS247550, Epothilone, Epothilone-B BMS 247550, Ixempra

Treatment (ixabepilone, temsirolimus)

Pharmacological Study OTHER

Correlative studies

Treatment (ixabepilone, temsirolimus)

Temsirolimus DRUG

Given IV

Also known as: CCI 779, CCI-779, CCI-779 Rapamycin Analog, CCI779, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel

Treatment (ixabepilone, temsirolimus)

Eligibility Criteria

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

You may qualify if:

• 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
• Patients may not have had more than two systemic therapeutic regimens in the metastatic disease setting with the following exceptions: hormonal therapy (e.g. tamoxifen, aromatase inhibitors, anti-androgen therapy, etc.)
• 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 glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x institutional upper limit of normal (ULN) in the absence of hepatic metastasis; SGPT (ALT) =\< 3 x ULN or SGOT (AST) =\< 5 x ULN in the presence 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)

You may not qualify if:

• 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:
• Pregnant women
• Nursing women

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

ixabepilone; Epothilones; temsirolimus; Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Keith C Bible

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 17, 2011
• Study Start: June 27, 2011
• Primary Completion: June 26, 2018
• Study Completion (Estimated): March 19, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

US (2)