A Study of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Prostate Cancer
NCT ID: NCT01106352 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-232

 

The main purpose of this study is to establish a recommended dose of Alpharadin® to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Christopher Sweeney, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org

Eligibility Criteria

Main Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate. - Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 12 weeks prior to study entry - Known castration-resistant disease - Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1) - Life expectancy at least 6 months. - Acceptable hematology and serum biochemistry screening values - Eligible for use of docetaxel according to the product information (package insert or similar). Main Exclusion Criteria: - Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period. - Has received external radiotherapy within the last 4 weeks prior to start of study treatment. - Has an immediate need for radiotherapy. - Has received prior hemibody external radiotherapy . - Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. - Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier. - Has received more than ten previous infusions of docetaxel. - Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation. - Previous use of G-CSF for persistent neutropenia after docetaxel treatment. - Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment. - Has received prior treatment with Alpharadin. - Malignant lymphadenopathy exceeding 3 cm in short-axis diameter. - Symptomatic nodal disease, i.e. scrotal, penile or leg edema. - Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment. - Uncontrolled loco-regional disease. - Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). - Has imminent or established spinal cord compression based on clinical findings and/or MRI. - Unmanageable fecal incontinence.
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