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CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00635245
Recruitment Status : Withdrawn
First Posted : March 13, 2008
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00635245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
  • Safety, tolerability and human anti-human antibodies (HAHA) response
  • Tissue markers
  • Measure of tumor glucose levels
  • Pathological response
  • Tumor size by MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
Official Title  ICMJE A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: figitumumab
  • Other: imaging biomarker analysis
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
  • Procedure: conventional surgery
  • Procedure: magnetic resonance spectroscopic imaging
  • Procedure: neoadjuvant therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
0
Original Enrollment  ICMJE
 (submitted: March 12, 2008)
19
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00635245
Other Study ID Numbers  ICMJE A4021012
P30CA077598 ( U.S. NIH Grant/Contract )
NCI-CDR0000589252
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Douglas Yee, MD Masonic Cancer Center, University of Minnesota
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP