- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121095
Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer
December 17, 2007 updated by: Cytogen Corporation
Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
69
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Colleen Gramkowski
- Phone Number: 8219 800-833-3533
- Email: cgramkowski@cytogen.com
Study Contact Backup
- Name: Melanie Giles
- Phone Number: 8112 800-833-3533
- Email: mgiles@cytogen.com
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Memorial Sloan-Kettering Cancer Center
-
Contact:
- Michael J Morris
- Phone Number: 646-422-4469
-
Principal Investigator:
- Michael J Morris, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
|
1 mCi/kg Sm153 + 75 mg/m2 docetaxel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Primary outcome is safety and tolerability of the combination treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Tumor response will be assessed when possible using RECIST criteria.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J Morris, M.D., Memorial Sloan Kettering Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
July 13, 2005
First Submitted That Met QC Criteria
July 19, 2005
First Posted (Estimate)
July 21, 2005
Study Record Updates
Last Update Posted (Estimate)
December 21, 2007
Last Update Submitted That Met QC Criteria
December 17, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Samarium Sm-153 lexidronam
Other Study ID Numbers
- 424Sm32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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