Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: June 6, 2001
Last updated: July 1, 2016
Last verified: July 2016

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.

Condition Intervention Phase
Prostate Cancer
Drug: carboplatin
Drug: estramustine
Drug: paclitaxel
Radiation: radiation therapy
Drug: leuprolide or goserelin acetate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 90 days and 1 year post treatment ]
    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.

Secondary Outcome Measures:
  • Time to Prostate-specific Antigen Failure [ Time Frame: 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). ]
    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.

  • Progression-free Survival (PFS) [ Time Frame: registration to progression, up to 5.5 years from registration ]
    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.

Enrollment: 34
Study Start Date: May 2001
Study Completion Date: May 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neo-Adj ChemoTx + ablation prior to RT
Patients 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.
Drug: carboplatin
AUC=6 week one of each 4 week cycle
Drug: estramustine
2 tablets tid PO 5 of 7 days per week each 4 week cycle
Drug: paclitaxel
80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
Radiation: radiation therapy
77.4 Gy in 1.8 Gy fractions
Drug: leuprolide or goserelin acetate
7.5 mg IM injection once every 4 weeks for 6 months

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


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


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


  • Creatinine no greater than 1.5 times ULN


  • 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


  • No pulmonary embolism within the past 6 months


  • Fertile patients must use effective contraception


Biologic therapy:

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


  • 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)


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


  • At least 4 weeks since prior major surgery


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00016913

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Oswego Hospital
Oswego, New York, United States, 13126
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, South Carolina
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States, 29401
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: William K. Kelly, DO Yale University
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00016913     History of Changes
Other Study ID Numbers: CALGB-99811
U10CA031946 ( US NIH Grant/Contract Award Number )
CDR0000068632 ( Registry Identifier: NCI Physician Data Query )
Study First Received: June 6, 2001
Results First Received: July 31, 2015
Last Updated: July 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the prostate
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 25, 2017