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Prostate CancerPhase 3NCT00024167

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

A Phase 3 study testing Docetaxel, Doxorubicin hydrochloride and Estramustine phosphate sodium in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 40 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Docetaxel, Doxorubicin hydrochloride and Estramustine phosphate sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
40 sitesUnited States
Study dates
Apr 2002to Sep 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rising PSA on at least 2 occasions >1 week apart (minimum value of 5 ng/ml), accompanied either by bone pain or, if the patient is asymptomatic, by a worsening bone scan with new lesions over a period of <6 months
  • Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 6 weeks; If progression is documented during this time interval as in inclusion criterion # 1, patients are eligible
  • Osteoblastic metastases on bone scan or CT scan
  • Androgen-independent prostate adenocarcinoma
  • Castrate testosterone level </= 50 ng/ml; treatment to maintain castrate levels of testosterone must be continued
  • >/= 18 years of age
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  • Life expectancy of greater than or equal to 12 weeks
  • Zubrod performance status </= 3
  • Patients must have normal organ and marrow function as defined below: Leukocytes greater than 3,000/mcL Absolute neutrophil count greater than 1,500/mcL Platelets greater than 100,000/mcL Total bilirubin less than or equal to 2X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2X institutional upper limit of normal
  • The patient must have the ability to understand and the willingness to sign a written informed consent document
  • Participating subjects and their female partners agree to the use of adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation

Who cannot join

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial
  • Prior doxorubicin, or vinblastine in the KAVE arm and prior docetaxel in the prednisone plus docetaxel arm. However, previous treatment using other secondary hormonal agents (aminoglutethimide, diethylstilbesterol, estramustine), steroids (dexamethasone, prednisone, hydrocortisone), angiogenesis inhibitors, gene therapy, or immunotherapy are allowed
  • More than one prior cytotoxic treatment
  • Prior Sr-89 or Sm-153 treatment
  • Patients who have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Previous vagotomy or other conditions (such as pernicious anemia) associated with achlorhydria. Patients with active peptic ulcer disease who still require regular use of H2 blockers (such as cimetidine [Tagamet], ranitidine [Zantac], famotidine [Pepcid], etc), proton pump inhibitors (omeprazole [Prilosec]), or antacids (Mylanta, Maalox, Tums, etc) at week 16 of induction chemotherapy (option 1 only) might not be suitable for randomization
Show all 12Show fewer
  • Predominant visceral metastases in the liver, lungs, or brain
  • Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria)
  • Small cell carcinoma
  • Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI) within 12 months, or active angina or claudication sufficient to limit activity
  • Active or likely to become active second malignancy (other than non-melanoma skin cancer)
  • Uncontrolled inter-current illness: including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Cancer Treatment Center

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether chemotherapy is more effective with or without strontium-89 in treating bone metastases.

PURPOSE: This randomized phase III trial is studying giving chemotherapy together with strontium-89 to see how well it works compared to chemotherapy alone in treating patients with prostate cancer that has spread to the bone.

Read the detailed description

OBJECTIVES:

  • Compare the effectiveness, in terms of overall survival, of consolidation therapy with or without strontium chloride Sr 89 after induction chemotherapy in patients with androgen-independent prostate cancer.

OUTLINE: This is a randomized study. Patients are stratified according to type of induction chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20 vs more than 20), Eastern Cooperative Oncology (ECOG) performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).

  • Induction therapy: Patients receive 1 of 2 induction therapy regimens.
  • Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8. Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients continue to receive oral ketoconazole three times daily until disease progression.

  • Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity.
  • Consolidation therapy: Patients with a prostate-specific antigen (PSA) response (at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA levels decreased at least 50% from baseline) are randomized to 1 of 2 consolidation treatment arms.
  • Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.
  • Arm II: Patients receive doxorubicin as in arm I. Patients are followed every 4 weeks until PSA progression and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this study within 48 months.

Conditions
Prostate Cancer
Being tested
Docetaxel, Doxorubicin hydrochloride, Estramustine phosphate sodium, Ketoconazole, Prednisone
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, Strontium-89, Induction Chemotherapy, Androgen-Independent Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.

  • Doxorubicin hydrochlorideDrug

    Also called Adriamycin PFS, Adriamycin RDF, Doxorubicin

    20 mg/m2 IV, day 1 on Weeks 1, 3, 5

  • Estramustine phosphate sodiumDrug

    Also called Estramustine

    140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6

  • KetoconazoleDrug

    Also called Nizoral

    400 mg orally (po) 3 x day, Days 1 through 7

  • PrednisoneDrug

    5 mg orally 2 x daily, weeks 1-14

  • VinblastineDrug

    Also called Velban

    4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6

  • Strontium chloride Sr 89Radiation

    Also called strontium-89 chloride, Sr-89, strontium-89, Metastron

    One dose (4 mCi total dose) IV

  • DexamethasoneDrug

    Also called Decadron

    4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.

Study groups in NCT00024167
Study groupRoleWhat they receive
Induction regimen AExperimentalDoxorubicin IV over 24 hours day 1; Oral ketoconazole 3 x daily on days 1-7 of weeks 1, 3, and 5; Vinblastine IV over 30 minutes Day 1, oral Estramustine 3 x daily on Days 1-7 of weeks 2, 4, and 6.
Receives: Drug: Doxorubicin hydrochloride; Drug: Estramustine phosphate sodium; Drug: Ketoconazole; Drug: Vinblastine
Induction regimen BExperimentalOral Prednisone 2 x daily on days 1-21 (days 1-14 of course 5 only) and Docetaxel IV over 1 hour Day 1.
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Dexamethasone
Consolidation arm IExperimentalDoxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
Receives: Drug: Doxorubicin hydrochloride; Radiation: Strontium chloride Sr 89
Consolidation arm IIExperimentalDoxorubicin as in Consolidation arm I.
Receives: Drug: Doxorubicin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival From Randomization

    Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.

    Measured: Followed every 4 weeks from randomization until death, up to 7 years.

Secondary outcomes (1)

  1. Overall Survival From Registration

    Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.

    Measured: Followed every 4 weeks from registration until death, up to 7 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionSep 2014

Why it stopped: Terminated due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024167
Sponsor's protocol ID
ID00-156
Other IDs
U10CA045809, P30CA016672, MDA-ID-00156, NCI-3410, CDR0000068897, NCI-2009-00009
Status last verified
Feb 2016
First submitted
13 Sep 2001
Last updated
22 Mar 2016
Data monitoring committee
Yes

Publications

  • Tu SM, Kim J, Pagliaro LC, Vakar-Lopez F, Wong FC, Wen S, General R, Podoloff DA, Lin SH, Logothetis CJ. Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy. J Clin Oncol. 2005 Nov 1;23(31):7904-10. doi: 10.1200/JCO.2005.01.2310.

    PubMed 16258090

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Doxorubicin hydrochloride and Estramustine phosphate sodium in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival From Randomization (time frame: Followed every 4 weeks from randomization until death, up to 7 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00024167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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