NCT00121095

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

July 13, 2005

Last Update Submit

December 17, 2007

Conditions

Prostatic Neoplasms

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is safety and tolerability of the combination treatment

Secondary Outcomes (1)

  • Tumor response will be assessed when possible using RECIST criteria.

Study Arms (1)

1

OTHER
Drug: Samarium Sm-153 lexidronam + Docetaxel

Interventions

Samarium Sm-153 lexidronam + DocetaxelDRUG

1 mCi/kg Sm153 + 75 mg/m2 docetaxel

1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

samarium Sm-153 lexidronamDocetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Michael J Morris, M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Gramkowski

CONTACT

800-833-3533cgramkowski@cytogen.com

Melanie Giles

CONTACT

800-833-3533mgiles@cytogen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Study Completion

June 1, 2008

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(1)