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Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)

Each cycle of treatment will consist of four weeks. The 2 types of medicines are given
intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is
given once a week for the first 3 weeks of each cycle. This is followed by a week of rest
until the next cycle starts. Treatment is given on an outpatient basis and hospitalization
is not anticipated.

Prior to entry on this study, "screening" tests are performed to determine eligibility to
participate. This will involve a complete history and physical examination, vital signs,
pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA
(prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are
abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the
abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life

After treatment starts the following tests are done to regularly monitor for beneficial and
toxic effect of the treatment:

Every week: blood tests.

Every month: physical examination, weight, vital signs (blood pressure, respiration,
temperature and heart rate) and PSA test.

Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and
possible pain films of bones if positive findings are seen on bone scan), computerized
tomography (CT) scans (abdomen and pelvis) and bone scans.

Participants may continue with any procedures that are part of their regular cancer care.
It is anticipated that participants will be in the study for a minimum of 2 months and as
long as they are benefiting from the treatment.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the

- Androgen-independent disease progression, as shown by:

- A castrate testosterone level of < 40 ng/dl (this measurement is required only for
patients treated with medical testicular suppression). If testicular suppression is
achieved medically, treatment to maintain castrate levels of testosterone must be
applied continuously.

- A PSA level of at least 4 ng/ml, and rising (with an absolute change of at least 1
ng/ml) on two consecutive measurements at least 2 weeks apart prior to study entry.

- Patients must be off anti-androgens such as flutamide (Eulexin) or nilutamide
(Nilandron) for at least four weeks, and six weeks for bicalutamide (Casodex),
without evidence of response; or have evidence of progression since anti-androgen

- None or one previous cytotoxic therapy is allowed. (For this study, a combination of
agents given at the same period of time is considered one chemotherapy treatment)

- Age > 18 years of age.

- Life expectancy of greater than 12 weeks.

- ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B).

- Patients must have adequate bone marrow function as defined below:

- absolute neutrophil count > 1,500/ul

- platelets > 100,000/ul

- hemoglobin > 8 g/dl

- Patients must have adequate liver function as defined below:

- total bilirubin normal, albumin > 3.0 g/dl, and no ascites

- AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be within the range
allowing for eligibility

- Patients must have adequate renal function as defined by a creatinine < 2.5 mg/dl or
a creatinine clearance > 30 mL/min (measured or estimated by the Cockroft formula)
for patients with creatinine levels above 2.5 mg/dl

- Patients must have recovered from acute toxicities from chemotherapy or radiotherapy
administered prior to entering this study. Alopecia may not be resolved and
peripheral neuropathy (grade 1) may be present.

- Patients must have a MUGA scan or 2-d echocardiogram indicating an ejection fraction
of > 50% within 42 days prior to first dose of study drug. The method used at
baseline must be used for later monitoring.

- Patients with reproductive potential must use an adequate contraceptive method (e.g.,
abstinence, intrauterine device, oral contraceptives, barrier device with spermicide
or surgical sterilization) during treatment and for three months after completing

- Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.

- Patients who have had two or more prior chemotherapy treatment(s) (For this study, a
combination of agents given at the same period of time is considered one chemotherapy

- Patients receiving any other investigational agent(s).

- Patients with symptomatic brain metastases or actively receiving any therapy for
brain metastasis (because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events).

- Active second malignancy in the last 5 years except for non-melanoma skin cancer or

- History of cardiac disease, with New York Heart Association Class II or greater, or
clinical evidence of congestive heart failure.

- History of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin HCL, the components of Doxil, docetaxel or other drugs formulated with
polysorbate 80.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and toxicity profile

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Damian Laber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center


United States: Food and Drug Administration

Study ID:

IRB# 575-03



Start Date:

January 2004

Completion Date:

August 2010

Related Keywords:

  • Prostate Cancer
  • Androgen Independent
  • Prostate Cancer
  • Taxotere
  • Doxil
  • AIPC
  • Advanced Androgen-Independent Prostate Cancer
  • Prostatic Neoplasms



James Graham Brown Cancer CenterLouisville, Kentucky  40202