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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Dexamethasone; Docetaxel; Prednisone; Radium Ra 223 dichloride; Succinylcholine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.

• Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 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).

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 or MRI 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