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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014