NCT00401765

Brief Summary

The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

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

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

4.2 years

First QC Date

November 17, 2006

Last Update Submit

May 23, 2014

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasmintravenousdocetaxelmonoclonal antibody

Outcome Measures

Primary Outcomes (3)

  • Number of Patients With Adverse Events as a Measure of Safety and Tolerability

    Up to 1 year after the last study medication administration

  • Plasma Concentration of Docetaxel

    predose, post dose (up to 6 hours), and Week 4 (end of treatment visit)

  • Serum Concentration of Docetaxel in Combination With CNTO 328

    predose, post dose (up to 6 hours), and up to Week 4 (end of treatment visit)

Secondary Outcomes (9)

  • Number of Patients with Prostate-Specific Antigen (PSA) Response

    Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first

  • Number of Patients With PSA Reduced Within 3 Months

    Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first

  • PSA Progression in Patients

    Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first

  • Duration of Tumor Response

    Screening phase (within 4 weeks before administration); every 3 weeks up to 14 cycles; and every 3 months up to 1 year after the last study medication administration

  • Duration of PSA response

    Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first

  • +4 more secondary outcomes

Study Arms (4)

Cohort 1A (Docetaxel and CNTO 328)

EXPERIMENTAL

In cohort 1A, 75 mg/m2 docetaxel will be administered in run-in phase and 75 mg/m2 docetaxel every 3 weeks and 6 mg/kg CNTO 328 every 2 weeks will be administered in the treatment phase.

Drug: CNTO 328Drug: Docetaxel

Cohort 1B (Docetaxel and CNTO 328)

EXPERIMENTAL

In cohort 1B, 6 mg/kg CNTO 328 will be administered in run-in phase and 75 mg/m2 docetaxel will be administered every 3 weeks plus 6 mg/kg CNTO 328 will be administered every 2 weeks in the treatment phase.

Drug: CNTO 328Drug: Docetaxel

Cohort 2 (Docetaxel and CNTO 328)

EXPERIMENTAL

In cohort 2, 75 mg/m2 docetaxel will be administered in run-in phase and 75 mg/m2 docetaxel plus 9 mg/kg CNTO 328 will be administered every 3 weeks in treatment phase.

Drug: CNTO 328Drug: Docetaxel

Cohort 3 (Doctaxel and CNTO 328)

EXPERIMENTAL

In cohort 3, 75 mg/m2 docetaxel will be administered in the run-in phase and 75 mg/m2 docetaxel plus 12 mg/kg CNTO 328 will be administered every 3 weeks in treatment phase.

Drug: CNTO 328Drug: Docetaxel

Interventions

CNTO 328DRUG

Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.

Cohort 1A (Docetaxel and CNTO 328)Cohort 1B (Docetaxel and CNTO 328)Cohort 2 (Docetaxel and CNTO 328)Cohort 3 (Doctaxel and CNTO 328)
DocetaxelDRUG

Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.

Cohort 1A (Docetaxel and CNTO 328)Cohort 1B (Docetaxel and CNTO 328)Cohort 2 (Docetaxel and CNTO 328)Cohort 3 (Doctaxel and CNTO 328)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Radiologically documented metastatic disease
  • No prior systemic chemotherapy for metastatic hormone refractory prostate cancer
  • Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression
  • Karnofsky performance status of greater than or equal to 60

You may not qualify if:

  • Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening
  • Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
  • Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
  • Known central nervous system metastases
  • Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES \[an herbal refined powder\]) within 4 weeks prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

siltuximabDocetaxel

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

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

September 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(5)