Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Androgens

Hormones

Leuprolide

Goserelin

Estramustine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

carboplatin

2 tablets tid PO 5 of 7 days per week each 4 week cycle

estramustine

80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle

paclitaxel

radiation therapy

7.5 mg IM injection once every 4 weeks for 6 months

leuprolide or goserelin acetate

William K. Kelly, DO

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.

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.

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

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

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.

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.

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.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.

Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.

Neo-Adj ChemoTx + Ablation Prior to RT

Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer	NCT00016913	Prostate Cancer	carboplatin estramustine paclitaxel radiation thera... leuprolide or g...	18 Years -	Alliance for Clinical Trials in Oncology
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer	NCT00016913	Prostate Cancer	carboplatin estramustine paclitaxel radiation thera... leuprolide or g...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for leuprolide or goserelin acetate