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

Primary Purpose

Prostatic Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Samarium Sm-153 lexidronam + Docetaxel
Sponsored by
Cytogen Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

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.

Full Information

First Posted
July 13, 2005
Last Updated
December 17, 2007
Sponsor
Cytogen Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00121095
Brief Title
Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer
Official Title
Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cytogen Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Samarium Sm-153 lexidronam + Docetaxel
Intervention Description
1 mCi/kg Sm153 + 75 mg/m2 docetaxel
Primary Outcome Measure Information:
Title
Primary outcome is safety and tolerability of the combination treatment
Secondary Outcome Measure Information:
Title
Tumor response will be assessed when possible using RECIST criteria.

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Gramkowski
Phone
800-833-3533
Ext
8219
Email
cgramkowski@cytogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Giles
Phone
800-833-3533
Ext
8112
Email
mgiles@cytogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Morris, M.D.
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Morris
Phone
646-422-4469
First Name & Middle Initial & Last Name & Degree
Michael J Morris, MD

12. IPD Sharing Statement

Learn more about this trial

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

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