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Sponsored by: |
Cytogen Corporation |
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Information provided by: | Cytogen Corporation |
ClinicalTrials.gov Identifier: | NCT00121095 |
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostatic Neoplasms |
Drug: Samarium Sm-153 lexidronam + Docetaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 69 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
---|---|
1 |
Drug: Samarium Sm-153 lexidronam + Docetaxel
1 mCi/kg Sm153 + 75 mg/m2 docetaxel
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The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined with docetaxel and prednisone. This present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. It enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Lab requirements:
Exclusion Criteria:
Contact: Colleen Gramkowski | 800-833-3533 ext 8219 | cgramkowski@cytogen.com |
Contact: Melanie Giles | 800-833-3533 ext 8112 | mgiles@cytogen.com |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Michael J Morris 646-422-4469 | |
Principal Investigator: Michael J Morris, MD |
Principal Investigator: | Michael J Morris, M.D. | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Cytogen Corporation ( Michael Manyak, MD ) |
Study ID Numbers: | 424Sm32 |
Study First Received: | July 13, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00121095 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Samarium ethylenediaminetetramethylenephosphonate |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses |
Physiological Effects of Drugs Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |