- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00635245
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Fas
- Fas 1
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
|---|
|
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
|
Sekundära resultatmått
Resultatmått |
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Patologiskt svar
|
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Safety, tolerability and human anti-human antibodies (HAHA) response
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Tissue markers
|
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Measure of tumor glucose levels
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Tumor size by MRI
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Douglas Yee, MD, Masonic Cancer Center, University of Minnesota
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A4021012
- P30CA077598 (U.S.S. NIH-anslag/kontrakt)
- NCI-CDR0000589252
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