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

August 5, 2008
April 9, 2013
June 2008
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
Progression free survival (PFS) at 12 weeks [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00728663 on ClinicalTrials.gov Archive Site
  • 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 ]
  • PFS at 24 weeks [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Prostate-specific antigen (PSA) response (30% and 50% PSA response) [ Designated as safety issue: No ]
  • Tumor assessment of measurable disease according to RECIST criteria [ Designated as safety issue: No ]
  • Tumor assessment of bone lesions [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer
Docetaxel and Cetuximab in Patients With Docetaxel-resistant Hormone-refractory Prostate Cancer (HRPC). A Multicenter Phase II Trial

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
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 ---

Interventions:
  • Biological: cetuximab
  • Drug: docetaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
April 2010
September 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00728663
SAKK 08/07, SWS-SAKK-08-07, MERCK-SAKK-0807, SANOFI-AVENTIS-SWS-SAKK-0807, CDR0000599858
No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
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
Swiss Group for Clinical Cancer Research
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP