NCT00080782

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin and strontium-89 with celecoxib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

April 7, 2004

Last Update Submit

October 30, 2018

Conditions

Metastatic CancerProstate Cancer

Keywords

recurrent prostate cancerstage IV prostate cancerbone metastasesProgressive Androgen-Independent Prostate CancerMetastronSr-89Strontium-89strontium chloride Sr 89CelecoxibCelebrexDoxorubicinRubexAdriamycin

Outcome Measures

Primary Outcomes (1)

  • Time to prostate-specific antigen progression

    Continuous assessment 16 weeks of treatment

Study Arms (2)

Arm I: Celecoxib

EXPERIMENTAL

Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1, and oral celecoxib twice daily in absence of disease progression.

Drug: CelecoxibDrug: Doxorubicin HydrochlorideRadiation: Strontium chloride Sr 89

Arm II: No Celecoxib

EXPERIMENTAL

Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.

Drug: Doxorubicin HydrochlorideRadiation: Strontium chloride Sr 89

Interventions

CelecoxibDRUG

Oral celecoxib twice daily in the absence of disease progression.

Also known as: Celebrex
Arm I: Celecoxib
Doxorubicin HydrochlorideDRUG

By vein (IV) over 30 minutes on days 1, 8, 15, and 22

Also known as: Adriamycin, Rubex
Arm I: CelecoxibArm II: No Celecoxib
Strontium chloride Sr 89RADIATION

IV on day 1

Also known as: Sr-89, Metastron, Strontium-89
Arm I: CelecoxibArm II: No Celecoxib

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of androgen-independent prostate cancer * Osteoblastic metastases * No predominant visceral metastases * Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment) * No symptomatic lymphadenopathy (i.e., scrotal or pedal edema) PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Adequate physiologic reserves PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No prior radionuclide therapy Surgery * Not specified Other * No more than 3 prior cytotoxic treatments * More than 6 months since prior celecoxib or rofecoxib

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisProstatic Neoplasms

Interventions

CelecoxibDoxorubicinstrontium chlorideStrontium-89

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Shi-Ming Tu, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

February 1, 2002

Primary Completion

April 1, 2004

Study Completion

January 1, 2005

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

US(1)