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Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer



- Compare the activity of docetaxel with or without oblimersen, in terms of
prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma
of the prostate.

- Compare the toxicity of these regimens in these patients.


- Compare the time to progression in patients treated with these regimens.

- Compare survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, metastatic disease (M0 vs M1 with non-measurable lesions only vs M1
with measurable lesions), prior estramustine (yes vs no), and prior bisphosphonates (yes vs
no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV
continuously on days 1-7.

- Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment
repeats every 21 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 8 weeks until progressive disease and then every 16 weeks

PROJECTED ACCRUAL: A total of 102 patients (51 per treatment arm) will be accrued for this

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Hormone-refractory disease

- Disease progression after prior hormonal therapy with luteinizing
hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens
(given together or consecutively)

- Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA
values over previous PSA reference value

- Must demonstrate continued PSA elevation for at least 6 weeks after
discontinuation of antiandrogen therapy

- PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week

- Testosterone ≤ 0.5 ng/mL* NOTE: *Patients with medical castration with LH-RH analogue
must continue with LH-RH analogue throughout the study

- No evidence of painful and/or destructive bone metastases requiring concurrent
radiotherapy, bisphosphonates, or bone-seeking radionuclides

- Other bone metastases allowed

- No clinical evidence of brain metastases



- 18 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 3,500/mm^3

- Hemoglobin ≥ 10 g/dL


- AST and ALT ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ ULN

- PTT and PT ≤ 1.5 times ULN OR

- INR ≤ 1.3


- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 50 mL/min


- No unstable angina

- No uncontrolled hypertension

- No deep venous thrombosis within the past 6 months

- No cerebrovascular accident, transient ischemic attack, or myocardial infarction
within the past 6 months


- No pulmonary embolism

- No history of interstitial pneumonitis

- No history of pulmonary fibrosis


- Adequate venous access

- HIV negative

- No active infection

- No pre-existing neuropathy

- No hypersensitivity to phosphorothioates

- No hypersensitivity to oligonucleotides or any other component of the oblimersen
formulation or to drugs formulated with polysorbate

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- No other malignancy within the past 5 years except adequately treated superficial
urothelial or skin cancer


Biologic therapy

- Not specified


- Prior estramustine allowed

- No other prior chemotherapy

- No concurrent estramustine

Endocrine therapy

- See Disease Characteristics

- At least 6 weeks since prior flutamide, bicalutamide, or nilutamide

- More than 6 weeks since prior hormonal manipulation with PC-SPES

- Concurrent LH-RH agonist allowed

- No concurrent antiandrogens


- See Disease Characteristics

- No prior radiotherapy involving > 25% of marrow-producing area

- No prior bone-seeking radionuclides

- No concurrent radiotherapy (including palliative therapy for painful bone metastases)

- No concurrent bone-seeking radionuclides


- See Disease Characteristics


- Prior bisphosphonates allowed

- No concurrent anticoagulation except for low-dose warfarin (1 mg/day)

- No concurrent regular (daily) intake of opioid analgesics

- No other concurrent experimental drugs or anticancer drugs

- No concurrent bisphosphonates

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses

Safety Issue:


Principal Investigator

Cora N. Sternberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Azienda Ospedaliera S. Camillo-Forlanini


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms