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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00635245
First received: March 12, 2008
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: figitumumab
Other: imaging biomarker analysis
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: conventional surgery
Procedure: magnetic resonance spectroscopic imaging
Procedure: neoadjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, tolerability and human anti-human antibodies (HAHA) response [ Designated as safety issue: Yes ]
  • Tissue markers [ Designated as safety issue: No ]
  • Measure of tumor glucose levels [ Designated as safety issue: No ]
  • Pathological response [ Designated as safety issue: No ]
  • Tumor size by MRI [ Designated as safety issue: No ]

Estimated Enrollment: 19
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635245

Sponsors and Collaborators
Pfizer
Investigators
Principal Investigator: Douglas Yee, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00635245     History of Changes
Other Study ID Numbers: A4021012, P30CA077598, NCI-CDR0000589252
Study First Received: March 12, 2008
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014