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

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: conventional surgery; Biological: figitumumab; Procedure: neoadjuvant therapy; Procedure: magnetic resonance spectroscopic imaging; Other: imaging biomarker analysis; Other: laboratory biomarker analysis; Other: pharmacological study

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00635245

NCI-CDR0000589252

P30CA077598 (U.S. NIH Grant/Contract)

A4021012

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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