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

Breast Cancer Clinical Trial

Official title:

A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00635245
• Other study ID #: A4021012
• Secondary ID: P30CA077598NCI-C
• Status: Withdrawn
• Phase: Phase 1
• First received: March 12, 2008
• Last updated: March 10, 2015

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• figitumumab

Other:
• imaging biomarker analysis

• laboratory biomarker analysis

• pharmacological study

Procedure:
• conventional surgery

• magnetic resonance spectroscopic imaging

• neoadjuvant therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy			No
Secondary	Safety, tolerability and human anti-human antibodies (HAHA) response			Yes
Secondary	Tissue markers			No
Secondary	Measure of tumor glucose levels			No
Secondary	Pathological response			No
Secondary	Tumor size by MRI			No