Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Prostate Cancer |
Biological: filgrastim Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: pain therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer |
| Study Start Date: | October 1999 |
OBJECTIVES: I. Determine the PSA response, duration of PSA response, disease free survival, median survival, and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel. II. Assess for any improvement in pain over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1, 22, 43, and 64, and docetaxel IV over 1 hour on days 85, 106, and 127 in the absence of disease progression or unacceptable toxicity. Patients receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions. Pain and analgesic use are assessed before study, every 3 weeks during study, after completion of study, and then at 3 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: Approximately 42-105 patients will be accrued for this study over 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate that is chemotherapy naive and refractory to hormonal therapy with combined androgen blockade No concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide at least 8 weeks before study enrollment, and must have disease progression off antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at least 2 weeks apart) or measurable tumor Concurrent LHRH antagonist allowed if no prior orchiectomy No minimum PSA level required Measurable or evaluable disease An increase in PSA or pain without measurable or evaluable disease does not constitute hormone refractory disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF normal No impaired cardiac status (e.g., history of severe heart disease, cardiomyopathy, or congestive heart failure) Other: No active infection, defined by the following: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, or urinary tract infection) Fever with a clinical site of infection identified Microbiologically documented infection including, but not limited to, bacteremia or septicemia HIV negative No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer No psychiatric, addictive, or other disorder that would preclude informed consent or compliance No hypersensitivity to E. coli derived proteins or drugs formulated with polysorbate 80 (e.g., human insulin)
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent WBC transfusions No other concurrent biologic therapy Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agent No concurrent acetaminophen for fever prophylaxis
Contacts and Locations| United States, California | |
| Wilshire Oncology Medical Group, Inc. | |
| Los Angeles, California, United States, 90057 | |
| United States, Florida | |
| Geffen Cancer Center and Research Institute | |
| Vero Beach, Florida, United States, 32960-6541 | |
| United States, New York | |
| Arena Oncology Associates | |
| Great Neck, New York, United States, 11021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| N.W. Carolina Oncology & Hematology, P.A. | |
| Hickory, North Carolina, United States, 28603 | |
| United States, Pennsylvania | |
| Associates of Hematology/Oncology | |
| Upland, Pennsylvania, United States, 19013 | |
| Study Chair: | Debra Litwak, PharmD | Amgen |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005960 History of Changes |
| Other Study ID Numbers: | CDR0000067942, AMGEN-GCSF-980282, NCI-V00-1595 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
stage III prostate cancer stage IV prostate cancer recurrent prostate cancer pain |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Cyclophosphamide Docetaxel Doxorubicin Lenograstim Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013