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

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005810
• Other study ID #: CALGB-99813
• Secondary ID: U10CA031946CDR00
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: July 12, 2016
• Start date: March 2000
• Est. completion date: June 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• docetaxel

• estramustine phosphate sodium

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Oncolog

Oh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B 99813. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Up to 2 years	No