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A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Pain, Prostate Cancer

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Trial Information

A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer

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

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

Inclusion Criteria

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Debra Litwak, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Pain
  • Prostate Cancer
  • 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
  • Prostatic Neoplasms



New York Medical College Valhalla, New York  10595
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Arena Oncology Associates Great Neck, New York  11021
N.W. Carolina Oncology & Hematology, P.A. Hickory, North Carolina  28603
Geffen Cancer Center and Research Institute Vero Beach, Florida  32960-6541
Associates of Hematology/Oncology Upland, Pennsylvania  19013