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

Information source: Cytogen Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: Samarium Sm-153 lexidronam + Docetaxel (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Cytogen Corporation

Official(s) and/or principal investigator(s):
Michael J Morris, M.D., Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Colleen Gramkowski, Phone: 800-833-3533, Ext: 8219, Email: cgramkowski@cytogen.com

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.

Clinical Details

Official title: Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Primary outcome is safety and tolerability of the combination treatment

Secondary outcome: Tumor response will be assessed when possible using RECIST criteria.

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Colleen Gramkowski, Phone: 800-833-3533, Ext: 8219, Email: cgramkowski@cytogen.com

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Michael J Morris, Phone: 646-422-4469
Michael J Morris, MD, Principal Investigator
Additional Information

Starting date: July 2005
Last updated: December 17, 2007

Page last updated: August 23, 2015

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