Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005810
First received: June 2, 2000
Last updated: July 31, 2010
Last verified: August 2006
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Biological: filgrastim
Drug: carboplatin
Drug: docetaxel
Drug: estramustine phosphate sodium
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

OBJECTIVES: I. Determine the response rate (objective and PSA response) and duration of response to estramustine, docetaxel, and carboplatin with filgrastim (G-CSF) support in patients with hormone refractory prostate cancer. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IV adenocarcinoma of the prostate Failure on standard hormone therapy Measurable disease with any PSA Accurately measured in at least 1 dimension as at least 20 mm by physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as at least 10 mm by spiral CT scan OR Nonmeasurable disease with PSA at least 5 ng/mL Nontarget lesions including small lesions with longest diameter less than 20 mm by conventional techniques or less than 10 mm by spiral CT scan and truly nonmeasurable lesions including: Bone lesions Pleural or pericardial effusions Ascites CNS lesions Leptomeningeal disease Irradiated lesions unless progression documented after radiotherapy Documented progressive systemic disease despite at least 1 endocrine manipulation with either orchiectomy or LHRH agonist (which must be continued), or diethylstilbestrol For measurable disease: Objective evidence of increase of greater than 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of 1 or more new lesions For nonmeasurable disease: If bone only disease, appearance of 1 new lesion on bone scan attributable to prostate cancer along with a PSA of at least 5 ng/mL OR An elevated PSA (at least 5 ng/mL) that has risen serially from baseline on 2 occasions each at least 1 week apart Testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy

PATIENT CHARACTERISTICS: Age: 18 to 99 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.0 times upper limit of normal (ULN) AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction or significant change in anginal pattern within past 1 year No congestive heart failure No New York Heart Association class II-IV heart disease No deep venous thrombosis or pulmonary embolus within past 1 year Other: Fertile patients must use effective contraception No clinically significant peripheral neuropathy No known hypersensitivity to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: No prior chemotherapy No prior estramustine or suramin No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior antiandrogens Primary testicular androgen suppression (e.g., with an LHRH analogue) should not be discontinued Concurrent LHRH analogue allowed if no prior bilateral orchiectomy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation and recovered At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent palliative radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005810

Locations
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: William Oh, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Oh WK, Halabi S, Kelly WK, et al.: A phase II study of estramustine, docetaxel, and carboplatin (EDC) with G-CSF support in men with hormone refractory prostate cancer (HRPC): CALGB 99813. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-779, 2002.

ClinicalTrials.gov Identifier: NCT00005810     History of Changes
Other Study ID Numbers: CDR0000067811, CLB-99813
Study First Received: June 2, 2000
Last Updated: July 31, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Estramustine
Docetaxel
Carboplatin
Sodium phosphate
Lenograstim
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014