Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-99811 NCT00016913

Objectives

1. Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer.
2. Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 60 patients will be accrued for this study within 1.5 years.

Outcomes

Acute and late toxicity

Time to prostate-specific antigen failure
Progression-free survival
Overall survival

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.

Kelly WK, Halabi S, Elfiky A, et al.: 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 113 (11): 3137-45, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

William Kelly, DO, Protocol chair		Ph: 203-737-2572

Registry Information
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
Trial Start Date		2001-05-15
Registered in ClinicalTrials.gov		NCT00016913
Date Submitted to PDQ		2001-03-30
Information Last Verified		2006-07-13
NCI Grant/Contract Number		CA31946

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