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Prostate CancerPhase 2NCT00016913

Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

A Phase 2 study testing carboplatin, estramustine and paclitaxel in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. 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?
carboplatin, estramustine and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
23 sitesUnited States
Study dates
May 2001to May 2008
Phase
Phase 2
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:
  • Tx N0, baseline prostate specific antigen (PSA) greater than 20 ng/mL, and Gleason score at least 7
  • T3b-4 N0, any baseline PSA, and any Gleason score
  • No pelvic lymph node disease requiring pelvic radiotherapy
  • No metastatic disease by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No significant cardiovascular disease
  • No New York Heart Association class III or IV congestive heart failure
  • No active angina pectoris
  • No myocardial infarction within the past 6 months
  • No history of hemorrhagic or thrombotic cerebral vascular accident
  • No deep vein thrombosis within the past 6 months

Pulmonary:

  • No pulmonary embolism within the past 6 months

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for prostate cancer
  • No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

  • No prior chemotherapy for prostate cancer
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No more than 6 weeks of prior androgen deprivation therapy
  • No other concurrent anticancer hormonal therapy except steroids for adrenal failure and/or hormones for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for prostate cancer
  • No other concurrent anticancer radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • No prior alternative therapy (e.g., PC-SPES) for prostate cancer
  • No concurrent alternative medicine (e.g., PC-SPES or saw palmetto) or large quantities of vitamins
  • No other concurrent anticancer therapy

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Oswego Hospital

    Oswego, New York, 13126

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Community General Hospital of Greater Syracuse

    Syracuse, New York, 13215

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Phase II Study Of Neo-Adjuvant Paclitaxel, Estramustine And Carboplatin (TEC) Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer.
  • Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses.

Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses.

After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Conditions
Prostate Cancer
Being tested
carboplatin, estramustine, paclitaxel, radiation therapy, leuprolide or goserelin acetate
Keywords
adenocarcinoma of the prostate, stage III 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.

  • carboplatinDrug

    AUC=6 week one of each 4 week cycle

  • estramustineDrug

    2 tablets tid PO 5 of 7 days per week each 4 week cycle

  • paclitaxelDrug

    80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle

  • radiation therapyRadiation

    77.4 Gy in 1.8 Gy fractions

  • leuprolide or goserelin acetateDrug

    7.5 mg IM injection once every 4 weeks for 6 months

Study groups in NCT00016913
Study groupRoleWhat they receive
Neo-Adj ChemoTx + ablation prior to RTExperimentalPatients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m^2 intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conformal or intensity-modulated radiotherapy (total dose of 77.4 gray [Gy] in 1.8-Gy fractions). All patients received androgen deprivation therapy with either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy.
Receives: Drug: carboplatin; Drug: estramustine; Drug: paclitaxel; Radiation: radiation therapy; Drug: leuprolide or goserelin acetate

What is being measured

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

  1. Toxicity

    Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.

    Measured: 90 days and 1 year post treatment

Secondary outcomes (2)

  1. Time to Prostate-specific Antigen Failure

    PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.

    Measured: PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).

  2. Progression-free Survival (PFS)

    PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.

    Measured: registration to progression, up to 5.5 years from registration

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 startMay 2001
  3. Primary completionJul 2007
  4. Study completionMay 2008

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016913
Sponsor's protocol ID
CALGB-99811
Other IDs
U10CA031946, CALGB-99811, CDR0000068632
Status last verified
Jul 2016
First submitted
6 Jun 2001
Last updated
6 Jul 2016
Data monitoring committee
No

Publications

  • Kelly WK, Halabi S, Elfiky A, Ou SS, Bogart J, Zelefsky M, Small E; Cancer Leukemia Group B. Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811. Cancer. 2008 Dec 1;113(11):3137-45. doi: 10.1002/cncr.23910.

    PubMed 18989865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, estramustine and paclitaxel in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 23 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?

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: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Jan 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?

Toxicity (time frame: 90 days and 1 year post treatment). 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 NCT00016913, 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 6 Jul 2016.

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