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Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00121095
Recruitment Status : Unknown
Verified December 2007 by Cytogen Corporation.
Recruitment status was:  Recruiting
First Posted : July 21, 2005
Last Update Posted : December 21, 2007
Information provided by:
Cytogen Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Samarium Sm-153 lexidronam + Docetaxel Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
Study Start Date : July 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
1 Drug: Samarium Sm-153 lexidronam + Docetaxel
1 mCi/kg Sm153 + 75 mg/m2 docetaxel

Primary Outcome Measures :
  1. Primary outcome is safety and tolerability of the combination treatment

Secondary Outcome Measures :
  1. Tumor response will be assessed when possible using RECIST criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have histological evidence of adenocarcinoma of the prostate.
  • Have progressive castrate metastatic disease.
  • Castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued.
  • Must have evidence of at least 3 bone metastases on bone scan.
  • Patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
  • Patients undergoing prior bisphosphonate treatments are eligible.
  • Patients who have received one prior treatment with 153Sm lexidronam or 89Sr are eligible provided it is at least 12 weeks from treatment with 153Sm lexidronam or 24 weeks from treatment with 89Sr.
  • Life expectancy of at least 12 weeks (based on co-morbidity).
  • KPS>60.
  • Lab requirements:

    • White Blood Count (WBC) ≥ 3,000/mm3;
    • Absolute Neutrophil Count (ANC) ≥ 1,500/ mm3;
    • Platelet (PLT) ≥ 100,000/mm3;
    • Hemoglobin (HGB) ≥ 10 mg/dl;
    • Bilirubin ≤ 2.0 mg/dl;
    • ALT/AST≤ 3 times the upper limit of normal;
    • Serum creatinine ≤ 2.0 mg/dl.
  • Patients must sign an informed consent.

Exclusion Criteria:

  • Patients with small cell carcinoma.
  • Patients with predominant visceral metastases (>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema).
  • Patients who have received more than one course of external beam radiation therapy directed at bone lesions.
  • Clinically significant cardiac disease (New York Heart Association Class III/IV).
  • History of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years.
  • Have or are participating in a research study protocol or clinical trial protocol within 30 days of the date of the baseline visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121095

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         
Sponsors and Collaborators
Cytogen Corporation
Principal Investigator: Michael J Morris, M.D. Memorial Sloan Kettering Cancer Center

Responsible Party: Michael Manyak, MD, Cytogen Corporation
ClinicalTrials.gov Identifier: NCT00121095     History of Changes
Other Study ID Numbers: 424Sm32
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Cytogen Corporation:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Samarium Sm-153 lexidronam
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs