A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
NCT ID: NCT01106352
Last Updated: 2017-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2010-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m\^2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone.
Radium-223 dichloride (Xofigo, BAY88-8223)
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.
Docetaxel
Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Docetaxel
Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Docetaxel
Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Interventions
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Radium-223 dichloride (Xofigo, BAY88-8223)
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.
Docetaxel
Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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San Francisco, California, United States
Evanston, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
Seattle, Washington, United States
Villejuif, , France
Countries
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References
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Morris MJ, Loriot Y, Sweeney CJ, Fizazi K, Ryan CJ, Shevrin DH, Antonarakis ES, Pandit-Taskar N, Deandreis D, Jacene HA, Vesselle H, Petrenciuc O, Lu C, Carrasquillo JA, Higano CS. Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Eur J Cancer. 2019 Jun;114:107-116. doi: 10.1016/j.ejca.2019.04.007. Epub 2019 May 11.
Gkialas IK, Fragkoulis C. Emerging therapies targeting castration-resistant prostate cancer. J BUON. 2015 Nov-Dec;20(6):1389-96.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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BC1-10
Identifier Type: OTHER
Identifier Source: secondary_id
2011-000822-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15469
Identifier Type: -
Identifier Source: org_study_id
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