CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00635245|
Recruitment Status : Withdrawn
First Posted : March 13, 2008
Last Update Posted : March 11, 2015
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 or disease||Intervention/treatment||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|
- To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer|
- Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
- Safety, tolerability and human anti-human antibodies (HAHA) response
- Tissue markers
- Measure of tumor glucose levels
- Pathological response
- Tumor size by MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635245
|Principal Investigator:||Douglas Yee, MD||Masonic Cancer Center, University of Minnesota|