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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Time Frame:
90 days and 1 year post tx
Safety Issue:
Yes
Principal Investigator
William K. Kelly, DO
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000068632
NCT ID:
NCT00016913
Start Date:
May 2001
Completion Date:
January 2013
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
| Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Oswego Hospital | Oswego, New York 13126 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Saint Luke's Hospital | Chesterfield, Missouri 63017 |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
