Back to resultsCP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
figitumumab
imaging biomarker analysis
laboratory biomarker analysis
pharmacological study
conventional surgery
magnetic resonance spectroscopic imaging
neoadjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed early operable adenocarcinoma of the breast
- No evidence of invasive lobular breast disease
- Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
- Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
- Must have available or scheduled core breast biopsy procedure
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Platelet count ≥ 100,000/mm^³
- Neutrophil count ≥ 1,500/mm³
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- ALT and AST < 2.5 times ULN
- Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
- Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- No known hypersensitivity to monoclonal antibodies
- No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
- No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
No significant active cardiac disease including any of the following:
- Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
- Unstable angina
- Deep venous thrombosis
- Pulmonary embolism
- Cerebrovascular attack
- Valvular disease
- Congestive heart failure
- Myocardial infarction with the past 6 months
- Serious cardiac arrhythmias
- No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior surgery and recovered
- More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
- No prior anti-IGF-1R based investigational therapy
- No prior systemic therapy for primary disease
No concurrent chronic systemic high-dose immunosuppressive steroid therapy
- Low-dose steroids for nausea and vomiting control allowed
- Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
- No concurrent other anticancer drugs or therapy
Sites / Locations
Outcomes
Primary Outcome Measures
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Secondary Outcome Measures
Safety, tolerability and human anti-human antibodies (HAHA) response
Tissue markers
Measure of tumor glucose levels
Pathological response
Tumor size by MRI
Full Information
NCT ID
NCT00635245
First Posted
March 12, 2008
Last Updated
March 10, 2015
Sponsor
Pfizer
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00635245
Brief Title
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
Official Title
A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.
Detailed Description
Primary
To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.
Secondary
To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients.
To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients.
To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients.
To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses).
OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.
After completion of study treatment, patients will be followed for 5 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
figitumumab
Intervention Type
Other
Intervention Name(s)
imaging biomarker analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Secondary Outcome Measure Information:
Title
Safety, tolerability and human anti-human antibodies (HAHA) response
Title
Tissue markers
Title
Measure of tumor glucose levels
Title
Pathological response
Title
Tumor size by MRI
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed early operable adenocarcinoma of the breast
No evidence of invasive lobular breast disease
Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
Must have available or scheduled core breast biopsy procedure
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Menopausal status not specified
ECOG performance status 0-1
Platelet count ≥ 100,000/mm^³
Neutrophil count ≥ 1,500/mm³
Creatinine < 1.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN
ALT and AST < 2.5 times ULN
Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
No known hypersensitivity to monoclonal antibodies
No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
No significant active cardiac disease including any of the following:
Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
Unstable angina
Deep venous thrombosis
Pulmonary embolism
Cerebrovascular attack
Valvular disease
Congestive heart failure
Myocardial infarction with the past 6 months
Serious cardiac arrhythmias
No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior surgery and recovered
More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
No prior anti-IGF-1R based investigational therapy
No prior systemic therapy for primary disease
No concurrent chronic systemic high-dose immunosuppressive steroid therapy
Low-dose steroids for nausea and vomiting control allowed
Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
No concurrent other anticancer drugs or therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Yee, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
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