DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: bicalutamide (Drug); buserelin (Drug); cyproterone acetate (Drug); docetaxel (Drug); estramustine phosphate sodium (Drug); flutamide (Drug); goserelin acetate (Drug); leuprolide acetate (Drug); nilutamide (Drug); triptorelin (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure); radiation therapy (Radiation)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: UNICANCER

Official(s) and/or principal investigator(s):
Karim Fizazi, MD, PhD, Study Chair, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Clinical Details

Official title: Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

Study design: Allocation: Randomized, Primary Purpose: Treatment

Primary outcome:

Survival rate, in terms of clinical and biological remission at 8 years

Prostate-specific antigen level at 3 months

Cancer progression as measured by ultrasound

Survival without clinical remission

Overall survival

Toxicity

Quality of life

Detailed description: OBJECTIVES:

- Compare the 8-year survival rate, in terms of clinical and biological remission, of

patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy.

- Compare the prostate-specific antigen level at 3 months in patients treated with these

regimens.

- Compare cancer progression by ultrasound in patients treated with these regimens.

- Compare survival without clinical remission of patients treated with these regimens.

- Compare the overall survival of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or

bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months.

- Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning

approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment. Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 3 months, and at 1 year. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Minimum age: N/A. Maximum age: 79 Years. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Locally advanced disease or at high risk for relapse

- No clinically or radiologically suspected metastases

- Prior lymphadenectomy required

- Meets at least 1 of the following criteria for poor prognosis:

- Gleason score greater than 7

- T3 or T4 disease

- Prostate-specific antigen greater than 20 ng/mL

- N1 disease

PATIENT CHARACTERISTICS: Age

- Under 80

Performance status

- ECOG 0-2

Life expectancy

- More than 10 years

Hematopoietic

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- AST and ALT no greater than 1. 5 times upper limit of normal (ULN)

- Bilirubin no greater than ULN

Renal

- Creatinine less than 1. 6 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular

- No uncontrolled or severe cardiovascular disease

- No prior thrombosis

Pulmonary

- No prior pulmonary embolus

Other

- No active infection

- No intolerance to aspirin

- No other prior malignancy except basal cell skin cancer

- No physical or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No prior hormonal therapy

- No other concurrent hormonal therapy

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- No other concurrent anticancer therapy

Locations and Contacts

Centre Paul Papin, Angers 49100, France

Hopital Saint Andre, Bordeaux 33075, France

Institut Bergonie, Bordeaux 33076, France

Hopital Ambroise Pare, Boulogne-Billancourt F-92104, France

Centre Regional Francois Baclesse, Caen 14076, France

Polyclinique du Parc, Cholet 49300, France

Centre Hospitalier Universitaire Henri Mondor, Creteil 94000, France

Clinique Sainte-Marguerite, Hyeres 83400, France

Centre Hospitalier Departemental, La Roche Sur Yon 85025, France

Centre Hospital Universitaire Hop Huriez, Lille 59037, France

Centre Hospital Regional Universitaire de Limoges, Limoges 87042, France

Polyclinique des Quatre Pavillons, Lormont 33310, France

Centre Leon Berard, Lyon 69008, France

CHU de la Timone, Marseille 13385, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille 13273, France

Hopital Clinique Claude Bernard, Metz 57072, France

Hopital Notre-Dame de Bon Secours, Metz 57038, France

Centre Hospitalier General de Mont de Marsan, Mont-de-Marsan 40000, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier 34298, France

Hopital Lapeyronie-CHU Montpellier, Montpellier 34295, France

CRLCC Nantes - Atlantique, Nantes-Saint Herblain 44805, France

Centre Catherine de Sienne, Nantes 02, France

Centre Antoine Lacassagne, Nice 06189, France

Hopital de la Croix St. Simon, Paris 75020, France

Hopital Europeen Georges Pompidou, Paris 75015, France

Hopital Saint Joseph, Paris 75674, France

Hopital Tenon, Paris 75970, France

Institut Curie Hopital, Paris 75248, France

Institut Jean Godinot, Reims 51056, France

Centre Eugene Marquis, Rennes 35042, France

Centre Hospitalier de Rodez, Rodez 12027, France

Centre Henri Becquerel, Rouen 76038, France

Centre Rene Huguenin, Saint Cloud 92211, France

Hopital Foch, Suresnes 92151, France

Institut Claudius Regaud, Toulouse 31052, France

Centre Hospitalier Universitaire Bretonneau de Tours, Tours 37044, France

Centre Alexis Vautrin, Vandoeuvre-les-Nancy 54511, France

Institut Gustave Roussy, Villejuif F-94805, France

Additional Information

Starting date: November 2002
Last updated: February 23, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017