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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
estramustine
paclitaxel
radiation therapy
leuprolide or goserelin acetate
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Walter Reed Army Medical Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Veterans Affairs Medical Center - Baltimore
  • UMASS Memorial Cancer Center - University Campus
  • Saint Luke's Hospital
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Memorial Sloan-Kettering Cancer Center
  • Oswego Hospital
  • CCOP - Hematology-Oncology Associates of Central New York
  • SUNY Upstate Medical University Hospital
  • Veterans Affairs Medical Center - Syracuse
  • Community General Hospital of Greater Syracuse
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Lenoir Memorial Cancer Center
  • Wilson Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Roper St. Francis Cancer Center at Roper Hospital
  • Bon Secours St. Francis Health System
  • CCOP - Greenville
  • Danville Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neo-Adj ChemoTx + ablation prior to RT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 6, 2001
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016913
Brief Title
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neo-Adj ChemoTx + ablation prior to RT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC=6 week one of each 4 week cycle
Intervention Type
Drug
Intervention Name(s)
estramustine
Intervention Description
2 tablets tid PO 5 of 7 days per week each 4 week cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
77.4 Gy in 1.8 Gy fractions
Intervention Type
Drug
Intervention Name(s)
leuprolide or goserelin acetate
Intervention Description
7.5 mg IM injection once every 4 weeks for 6 months
Primary Outcome Measure Information:
Title
Toxicity
Description
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.
Time Frame
90 days and 1 year post treatment
Secondary Outcome Measure Information:
Title
Time to Prostate-specific Antigen Failure
Description
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.
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).
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
registration to progression, up to 5.5 years from registration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William K. Kelly, DO
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Saint Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Oswego Hospital
City
Oswego
State/Province
New York
ZIP/Postal Code
13126
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Community General Hospital of Greater Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Lenoir Memorial Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893-3428
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Roper St. Francis Cancer Center at Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18989865
Citation
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.
Results Reference
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Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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