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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cancer and Leukemia Group B.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00016913
First received: June 6, 2001
Last updated: April 10, 2012
Last verified: April 2011
  Purpose

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
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 90 days and 1 year post tx ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to prostate-specific antigen failure [ Time Frame: Wk 1 ea chemotx cycle & in follow up ] [ Designated as safety issue: No ]
    Follow up is q 3 mon for 2 yrs then q 6 mon for 4 years

  • Progression-free survival [ Time Frame: registration to progression ] [ Designated as safety issue: No ]
    progression includes PSA, local or distant ds, or death

  • Overall survival [ Time Frame: 6 years post treatment ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: May 2001
Estimated Study Completion Date: January 2013
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neo-Adj ChemoTx + ablation prior to RT
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
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
7.5 mg IM injection once every 4 weeks for 6 months
Other Name: GnRH

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00016913

Locations
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
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
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
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
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
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: William K. Kelly, DO Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00016913     History of Changes
Other Study ID Numbers: CDR0000068632, U10CA031946, CALGB-99811
Study First Received: June 6, 2001
Last Updated: April 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
adenocarcinoma of the prostate
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Paclitaxel
Carboplatin
Estramustine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 16, 2014