Phase 2
N=48
Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Male Breast Carcinoma · Recurrent Breast Carcinoma · Stage IV Breast Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT00699491 ↗Enrolled (actual)
48
Serious AEs
31.3%
Results posted
May 2015
Primary outcome: Primary: Recommended Dose Level for Phase II Testing (RPTD) (Phase I) — 2; 1; 1; 0 DLTs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cixutumumab (Biological); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Temsirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Dose Level for Phase II Testing (RPTD) (Phase I) |
2; 1; 1; 0; 3 | — |
| PRIMARY Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) |
— | — |
| SECONDARY Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II) |
8; 1 | — |
| SECONDARY Duration of Response (Phase II) |
— | — |
| SECONDARY Progression Free Survival (PFS) (Phase II) |
2.0 | — |
| SECONDARY Progression Free Survival Rate |
14.3 | — |
| SECONDARY Survival Time (Phase II) |
10.1 | — |
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.
Eligibility Criteria
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 = = 1,500/mcL
- Hemoglobin >= 8.5 g/dL
- Platelets >= 100,000/mcL
- Total bilirubin = = 60 mL/min/1.73^2 for patients with creatinine > institutional ULN
- Fasting serum cholesterol = = 3.4 mg/dL
- Fasting or non fasting serum glucose = 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: = = 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
Data sourced from ClinicalTrials.gov (NCT00699491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.