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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: March 12, 2008
• First Posted Date: March 13, 2008
• Last Update Posted Date: March 11, 2015
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 12, 2008): Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 1
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 10, 2015): 0
• Original Enrollment (submitted: March 12, 2008): 19
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00635245
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Douglas Yee, MD; Masonic Cancer Center, University of Minnesota

• PRS Account: Pfizer
• Verification Date: March 2015