Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00016913

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Paclitaxel Carboplatin Estramustine phosphate sodium Leuprolide Leuprolide acetate Estramustine Estramustine phosphate

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

William K. Kelly, DO

Yale University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Kelly WK, Halabi S, Elfiky A, Ou SS, Bogart J, Zelefsky M, Small E; for the 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 Nov 6; [Epub ahead of print]

Responsible Party:	Monica M Bertagnolli, 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 1, 2011
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
Estramustine
Leuprolide
Carboplatin
Paclitaxel
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012