Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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 thereafter.

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

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - Copenhagen University Hospital
  • France
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
      • Rome, Italy, 00152
        • Ospedale S. Camillo-Forlanini
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Lisboa, Portugal, 2700
        • Hospital Desterro
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d'Hebron
  • United Kingdom
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,500/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • PTT and PT ≤ 1.5 times ULN OR
  • INR ≤ 1.3

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • 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

Pulmonary

  • No pulmonary embolism
  • No history of interstitial pneumonitis
  • No history of pulmonary fibrosis

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • See Disease Characteristics

Other

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses

Secondary Outcome Measures

Outcome Measure
Time to progression as measured by RECIST and Bubley criteria every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Toxicity as measured by CTCAE v3.0 every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Cora N. Sternberg, MD, FACP, Azienda Ospedaliera S. Camillo-Forlanini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (Estimate)

June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30021
  • AVENTIS-AVE3139E/2501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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