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

Original Study ID : 424Sm32

NCT ID : 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

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.

Source : Cytogen Corporation

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.

Overall Status : Recruiting

Start Date : July 2005

End Date : June 2008

Completion Date : June 2008

Official Title : Phase 1/Phase 2

Phase : Interventional

Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Enrollment : 69

Verification Date : December 2007

First Received Date : July 13, 2005

Trial 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.

Gender : Male

Minimum Age : N/A

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Memorial Sloan-Kettering Cancer Center

Status : Recruiting

City : New York

State : New York

Zip Code : 10021

Country : United States

OutComes

Primary OutComes

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

Secondary OutComes

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

Interventions

Type : Drug

Name : Samarium Sm-153 lexidronam + Docetaxel

Description : 1 mCi/kg Sm153 + 75 mg/m2 docetaxel

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