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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00121095
• Date of registration: 13/07/2005
• Prospective Registration: No
• Primary sponsor: Cytogen Corporation
• Public title: Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer
• Scientific title: Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
• Date of first enrolment: July 2005
• Target sample size: 69
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00121095
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Michael J Morris, M.D.
• Affiliation: Memorial Sloan Kettering Cancer Center.

• Name: Colleen Gramkowski

• Name: Michael J Morris

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Drug: Samarium Sm-153 lexidronam + Docetaxel

Primary Outcome(s)

Primary outcome is safety and tolerability of the combination treatment

Secondary Outcome(s)

Tumor response will be assessed when possible using RECIST criteria.

Secondary ID(s)

424Sm32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors