Clinical trial NCT00635245: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-03-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Secondary outcomes:
measure: Safety, tolerability and human anti-human antibodies (HAHA) response
measure: Tissue markers
measure: Measure of tumor glucose levels
measure: Pathological response
measure: Tumor size by MRI
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Douglas Yee, MD
role: PRINCIPAL_INVESTIGATOR
References: