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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00699491
Other study ID # NCI-2009-00284
Secondary ID NCI-2009-00284CD
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 31, 2008
Est. completion date February 14, 2018

Study information

Verified date May 2018
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.


Description:

PRIMARY OBJECTIVES:

I. To establish the recommended dose level for the phase II trial. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of IMC-A12 (cixutumumab) in combination with temsirolimus in patients with metastatic breast cancer. (Phase II)

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate).

II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with IMC-A12 and to examine potential biomarker predictors of treatment response.

OUTLINE: This is a phase I, dose-escalation study of cixutumumab followed by a phase II study.

Patients receive temsirolimus intravenously (IV) over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 14, 2018
Est. primary completion date September 9, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed diagnosis of breast cancer with diagnosis of metastatic or locally recurrent disease (locally recurrent disease should be stage IV e.g. chest wall involvement)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (Karnofsky >= 80%)

- Life expectancy of > 12 weeks

- Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent

- Negative serum pregnancy test =< 7 days of registration for women of childbearing potential:

- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12 and CCI-779 (temsirolimus)

- Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

- Nursing women must be willing to discontinue nursing; NOTE: breastfeeding should be discontinued if the mother is treated with CCI-779 and IMC-A12

- Absolute neutrophil count >= 1,500/mcL

- Hemoglobin >= 8.5 g/dL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 X institutional ULN if liver function test [LFT] elevations due to liver metastases)

- Creatinine =< 1.5 X institutional ULN OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine > institutional ULN

- Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)

- Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)

- Albumin >= 3.4 mg/dL

- Fasting or non fasting serum glucose < 120 mg/dL

- Hemoglobin A1c (HbA1c) (for all patients with a history of diabetes mellitus) < 8%

- Phase I only: Any number of prior therapy regimens is allowed

- Phase II only: Measurable disease is required for the Phase II portion of the study; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], x-ray) or as >= 10 mm with spiral CT scan

- Phase II only: =< two and at least one prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease are required

Exclusion Criteria:

- Phase I patients only: Patients with base line diabetes requiring oral hypoglycemics or insulin

- Phase II patients only: Poorly controlled diabetes mellitus; NOTE: patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate contraception (hormonal agents are not allowed and oral contraceptives are not acceptable for contraception)

- Receiving hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist

- Any of the following prior therapies:

- Systemic anti-cancer therapy =< 3 weeks prior to registration

- Radiation therapy =< 2 weeks prior to registration

- Prior invasive non-breast malignancy, except for adequately treated basal or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for >= 5 years

- Known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin); allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12, or temsirolimus

- Prior treatment with agents targeting the insulin-like growth factor-I receptor (IGF-IR)/insulin-like growth factors (IGFs) or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) pathway

- Receiving any other investigational agents or herbal preparations

- Patients may not be taking oral corticosteroids except for replacement for adrenal insufficiency

- Uncontrolled brain metastases; Note: brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for >= 12 weeks

- Known human immunodeficiency virus (HIV)-positive patients who have cluster of differentiation (CD)4 counts below the normal range or who are on anti-retroviral therapy that may interfere with the metabolism of temsirolimus

- Uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled symptomatic cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study requirements

- Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Cixutumumab
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Drug:
Temsirolimus
Given IV

Locations

Country Name City State
United States Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Randolph Hospital Asheboro North Carolina
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Boulder Community Hospital Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Cooper Hospital University Medical Center Camden New Jersey
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Weiss Memorial Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Cancer Research Program NCORP Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Saint John Hospital and Medical Center Detroit Michigan
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Union Hospital of Cecil County Elkton Maryland
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Wayne Hospital Greenville Ohio
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Castle Medical Center Kailua Hawaii
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Beebe Medical Center Lewes Delaware
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Saint Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Florida Hospital Orlando Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Medical Oncology Consultants Pleasanton California
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Reid Health Richmond Indiana
United States Mayo Clinic Rochester Minnesota
United States Saint Mary's of Michigan Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Flower Hospital Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States Legacy Salmon Creek Hospital Vancouver Washington
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Fulton County Health Center Wauseon Ohio
United States Saint Ann's Hospital Westerville Ohio
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Greene Memorial Hospital Xenia Ohio
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended Dose Level for Phase II Testing (RPTD) (Phase I) The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.
Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:
Any grade 4 hematologic toxicity
Hyperglycemia that cannot be stably controlled with diabetic medication
Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)
During first course
Primary Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.
Complete Response (CR): All of the following must be true:
Disappearance of all target and non-target lesions.
Each target lymph node must have reduction in short axis to <1.0 cm.
Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.
The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach.
Up to 5 years
Secondary Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II) Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported. Up to 5 years
Secondary Duration of Response (Phase II) Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method. Up to 5 years
Secondary Progression Free Survival (PFS) (Phase II) Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method. Time from registration to documentation of disease progression, up to 5 years
Secondary Progression Free Survival Rate Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method. At 6 months
Secondary Survival Time (Phase II) Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Time from registration to death due to any cause
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