Recruiting
Phase 1
Phase 2

Samarium Sm-153 & Docetaxel

Sponsor:

Cytogen Corporation

Code:

NCT00121095

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Samarium Sm-153 lexidronam + Docetaxel

Study Details

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.

Conditions

Prostatic Neoplasms

Study ID

NCT00121095

Start date

Jul, 2005

Status verified date

Dec, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

69 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 1

Interventions

Samarium Sm-153 lexidronam + Docetaxel

1 mCi/kg Sm153 + 75 mg/m2 docetaxel

Primary outcome measure

  • Primary outcome is safety and tolerability of the combination treatment [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Colleen Gramkowski

800-833-3533cgramkowski@cytogen.com

Melanie Giles

800-833-3533mgiles@cytogen.com

Locations

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Michael J Morris

646-422-4469

Principal Investigator:

Michael J Morris, MD

More Information

Sponsor

Cytogen Corporation

Last update posted

Dec 21, 2007

Last verified

Dec, 2007

Keywords

  • prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cytogen Corporation on 2007-12-21.