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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

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 CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
CCOP - GreenvilleGreenville, South Carolina  29615
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
SUNY Upstate Medical University HospitalSyracuse, New York  13210
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Oswego HospitalOswego, New York  13126
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Danville Regional Medical CenterDanville, Virginia  24541
Saint Luke's HospitalChesterfield, Missouri  63017
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401