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

NCT ID: NCT00016913

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2008-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neo-Adj ChemoTx + ablation prior to RT

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.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

AUC=6 week one of each 4 week cycle

estramustine

Intervention Type: DRUG

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

paclitaxel

Intervention Type: DRUG

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

radiation therapy

Intervention Type: RADIATION

77.4 Gy in 1.8 Gy fractions

leuprolide or goserelin acetate

Intervention Type: DRUG

7.5 mg IM injection once every 4 weeks for 6 months

Interventions

carboplatin

AUC=6 week one of each 4 week cycle

Intervention Type: DRUG

estramustine

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

Intervention Type: DRUG

paclitaxel

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

Intervention Type: DRUG

radiation therapy

77.4 Gy in 1.8 Gy fractions

Intervention Type: RADIATION

leuprolide or goserelin acetate

7.5 mg IM injection once every 4 weeks for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William K. Kelly, DO

Role: STUDY_CHAIR

Yale University

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, United States

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, United States

Saint Luke's Hospital

Chesterfield, Missouri, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Oswego Hospital

Oswego, New York, United States

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, United States

Community General Hospital of Greater Syracuse

Syracuse, New York, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Lenoir Memorial Cancer Center

Kinston, North Carolina, United States

Wilson Medical Center

Wilson, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, United States

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

Danville Regional Medical Center

Danville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18989865 (View on PubMed)

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-99811

Identifier Type: -

Identifier Source: secondary_id

CDR0000068632

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-99811

Identifier Type: -

Identifier Source: org_study_id