Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00728663
First received: August 5, 2008
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with cetuximab and to see how well it works in treating patients with metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Biological: cetuximab
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel and Cetuximab in Patients With Docetaxel-resistant Hormone-refractory Prostate Cancer (HRPC). A Multicenter Phase II Trial

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: All AEs will be assessed according to NCI CTCAE v3.0. ] [ Designated as safety issue: Yes ]
  • Prostate-specific antigen (PSA) response (30% and 50% PSA response) [ Time Frame: is defined as a decrease in PSA level of at least 50% (compared to baseline PSA) confirmed after 3-4 weeks (according to the PSA working group consensus criteria) ] [ Designated as safety issue: No ]
  • Tumor assessment of measurable disease according to RECIST criteria [ Time Frame: after 12 weeks of treatment, or earlier if clinically indicated ] [ Designated as safety issue: No ]
  • Tumor assessment of bone lesions [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: calculated from registration until death. ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm: Cetuximab and Docetaxel

Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8 and Docetaxel: 75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Biological: cetuximab

Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Other Name: Erbitux
Drug: docetaxel

75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Other Name: Taxotere

Detailed Description:

OBJECTIVES:

  • To assess the efficacy and safety of docetaxel and cetuximab in patients with docetaxel-resistant hormone-refractory prostate cancer

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly and docetaxel IV on day 1 (3-week courses) or on days 1, 8, and 15 (4-week courses). Treatment repeats every 3 weeks for up to 8 courses or every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Metastatic adenocarcinoma of the prostate
  • Must have received one of the following treatment schedules for at least 12 weeks prior to study therapy:

    • Docetaxel 75 mg/m^2 on day 1 of a 21-day course
    • Docetaxel 35 mg/m^2 on days 1, 8, and 15 of a 28-day course
  • Must demonstrate hormone-resistance, defined as tumor progression after orchiectomy or during treatment with hormonal agents (i.e., luteinizing hormone-releasing hormone [LHRH] agonists)
  • Elevated prostate-specific antigen (PSA) > 2 ng/mL and PSA progression after at least 12 weeks treatment with docetaxel/prednisone, within 90 days after discontinuation of docetaxel/prednisone treatment, under continued hormonal treatment (i.e., LHRH agonists or orchiectomy), and meets 1 of the following criteria for PSA progression:

    • PSA increase of ≥ 25% above the nadir
    • PSA increase of ≥ 25% above the baseline if no decrease has been observed

      • The increase is a minimum of 2 ng/mL, and it is confirmed 1 week later
  • No presence or history of CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Neutrophils ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • Peripheral neuropathy < grade 2
  • No prior malignancy within the past 5 years with the exception of localized nonmelanoma skin cancer or Ta or Tis bladder cancer
  • No known hypersensitivity to trial drugs or any of their components
  • No serious underlying medical condition that, in the judgment of the investigator, would preclude the patient's ability to participate in the trial (e.g., active autoimmune disease, uncontrolled or acute severe infection, or uncontrolled diabetes)
  • No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with oral drug intake compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy
  • More than 6 weeks since prior treatment with antiandrogens (i.e., flutamide or bicalutamide)
  • No prior chemotherapy other than docetaxel for metastatic prostate cancer
  • No other concurrent experimental drugs or other anticancer therapy

    • Concurrent bisphosphonates and LHRH agonists allowed provided these medications started at least 2 months prior to study therapy
  • No treatment in a clinical trial within the past 30 days
  • No prior treatment with drugs interacting with epidermal growth factor receptor (i.e., cetuximab, panitumumab, gefitinib, erlotinib hydrochloride, or multi-tyrosine kinase inhibitors)
  • No concurrent drugs that, according to the Swissmedic-approved product information, are contraindicated for use with the trial drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728663

Locations
Switzerland
Kantonspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
Saint Claraspital AG
Basel, Switzerland, CH-4016
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Spitalzentrum Biel
Biel, Switzerland, CH-2501
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
AndreasKlinik Cham Zug
Cham, Switzerland, CH-6330
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Kantonsspital Freiburg
Freiburg, Switzerland, 1708
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital, Luzerne
Luzerne, Switzerland, CH-6000
Kantonsspital Olten
Olten, Switzerland, CH-4600
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Klinik Hirslanden
Zurich, Switzerland, CH-8032
City Hospital Triemli
Zurich, Switzerland, CH-8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Onkozentrum
Zurich, Switzerland, 8038
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Richard Cathomas, MD Kantonsspital Graubuenden
Principal Investigator: Roger von Moos, MD Kantonsspital Graubuenden
Principal Investigator: Silke Gillessen, MD Cantonal Hospital of St. Gallen
  More Information

Additional Information:
Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00728663     History of Changes
Other Study ID Numbers: SAKK 08/07, SWS-SAKK-08-07, MERCK-SAKK-0807, SANOFI-AVENTIS-SWS-SAKK-0807, CDR0000599858
Study First Received: August 5, 2008
Last Updated: April 9, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014