Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Cytogen Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cytogen Corporation
ClinicalTrials.gov Identifier:
NCT00121095
First received: July 13, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cytogen Corporation:

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

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

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
Other Name: Samarium Sm-153 lexidronam + Docetaxel

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121095

Contacts
Contact: Colleen Gramkowski 800-833-3533 ext 8219 cgramkowski@cytogen.com
Contact: Melanie Giles 800-833-3533 ext 8112 mgiles@cytogen.com

Locations
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
Investigators
Principal Investigator: Michael J Morris, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Michael Manyak, MD, Cytogen Corporation
ClinicalTrials.gov Identifier: NCT00121095     History of Changes
Other Study ID Numbers: 424Sm32
Study First Received: July 13, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cytogen Corporation:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Samarium ethylenediaminetetramethylenephosphonate
Analgesics
Analgesics, Non-Narcotic
Antimitotic Agents
Antineoplastic Agents
Central Nervous System Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014