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

NCT00085228 | Completed Phase 2

• 2 other identifiers: EORTC-30021AVENTIS-AVE3139E/2501
• Study Type: interventional
• Target: 116
• Locations: 11 countries
• Sites: 16

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Interventions

oblimersen sodium BIOLOGICAL

docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (16)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Ospedale S. Camillo-Forlanini

Rome, 00152, Italy

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Hospital Desterro

Lisbon, 2700, Portugal

Location

Hospital General Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

• Sternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17.

  PMID: 19297314 RESULT

• Sternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

oblimersen; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Cora N. Sternberg, MD, FACP

  Azienda Ospedaliera S. Camillo-Forlanini

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2004
• Primary Completion: January 1, 2006
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

AU (1); IT (1); BE (5); DK (1); FR (1); PL (1); GB (2); PT (1); NL (1); IL (1); ES (1)