NCT00134706

Brief Summary

The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with drugs such as docetaxel. The investigators are also studying whether the measurement of two proteins in the blood may predict who will respond to the combination of docetaxel and carboplatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

6 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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

2.2 years

First QC Date

August 24, 2005

Last Update Submit

December 7, 2009

Conditions

Prostate Cancer

Keywords

Prostate CancerCancer of the prostateCancer of prostateDocetaxelCarboplatin

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to determine the efficacy and safety of docetaxel plus carboplatin as salvage chemotherapy in patients with hormone refractory prostate cancer who have progressed on prior docetaxel-based chemotherapy.

    2 years

Secondary Outcomes (1)

  • The secondary objective is to correlate the clinical and prostate-specific antigen (PSA) response with baseline serum chromogranin A (CGA) and neuron-specific enolase (NSE) levels.

    2 years

Interventions

DocetaxelDRUG

Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.

CarboplatinDRUG

Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate
  • Evidence of metastatic disease
  • Disease progression following androgen deprivation therapy
  • Disease progression despite docetaxel-based chemotherapy
  • Serum testosterone levels less than 50ng/ml (unless surgically castrated). Patients must continue androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.
  • No use of antiandrogens for at least 4 weeks
  • Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
  • Acceptable white blood cell (WBC), platelets, creatinine and AST counts

You may not qualify if:

  • Significant peripheral neuropathy defined as grade 2 or higher
  • Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium)
  • Prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory prostate cancer
  • Concomitant chemotherapy, investigational agents or systemic steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Wentworth Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Mary-Ellen Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

January 1, 2004

Primary Completion

April 1, 2006

Study Completion

September 1, 2009

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

US(6)