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Prostate CancerPhase 2NCT00728663

Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing cetuximab and docetaxel in people with Prostate Cancer, run by Swiss Cancer Institute at 21 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
cetuximab and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
21 sitesSwitzerland
Study dates
Jun 2008to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Switzerland21 sites

  • Kantonspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Inselspital Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • AndreasKlinik Cham Zug

    Cham, CH-6330

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Kantonsspital Freiburg

    Fribourg, 1708

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Kantonsspital, Luzerne

    Luzerne, CH-6000

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Onkozentrum

    Zurich, 8038

  • Klinik Hirslanden

    Zurich, CH-8032

  • City Hospital Triemli

    Zurich, CH-8063

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
cetuximab, docetaxel
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    Also called Erbitux

    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 ---

  • docetaxelDrug

    Also called Taxotere

    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 ---

Study groups in NCT00728663
Study groupRoleWhat they receive
Arm: Cetuximab and DocetaxelExperimentalCetuximab: 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 ---
Receives: Biological: cetuximab; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: at 12 weeks

  2. Progression-free survival (PFS)

    Measured: at 24 weeks

Secondary outcomes (5)

  1. Adverse events

    Measured: All AEs will be assessed according to NCI CTCAE v3.0.

  2. Prostate-specific antigen (PSA) response (30% and 50% PSA response)

    Measured: 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)

  3. Tumor assessment of measurable disease according to RECIST criteria

    Measured: after 12 weeks of treatment, or earlier if clinically indicated

  4. Tumor assessment of bone lesions

    Measured: at 12 weeks

  5. Overall survival

    Measured: calculated from registration until death.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2009
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00728663
Sponsor's protocol ID
SAKK 08/07
Other IDs
SWS-SAKK-08-07, MERCK-SAKK-0807, SANOFI-AVENTIS-SWS-SAKK-0807, CDR0000599858
Status last verified
Apr 2014
First submitted
5 Aug 2008
Last updated
14 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Cathomas R, Rothermundt C, von Moos R, et al.: Cetuximab in combination with docetaxel in patients (pts) with metastatic castration resistant (mCRPC) and docetaxel-refractory prostate cancer: A multicenter phase II trial (SAKK 08/07). [Abstract] J Clin Oncol 28 (Suppl 15): A-4666 , 2010.

  • Cathomas R, Rothermundt C, Klingbiel D, Bubendorf L, Jaggi R, Betticher DC, Brauchli P, Cotting D, Droege C, Winterhalder R, Siciliano D, Berthold DR, Pless M, Schiess R, von Moos R, Gillessen S; Swiss Group for Clinical Cancer Research SAKK. Efficacy of cetuximab in metastatic castration-resistant prostate cancer might depend on EGFR and PTEN expression: results from a phase II trial (SAKK 08/07). Clin Cancer Res. 2012 Nov 1;18(21):6049-57. doi: 10.1158/1078-0432.CCR-12-2219. Epub 2012 Sep 12.

    PubMed 22977195

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and docetaxel in people with Prostate Cancer, run by Swiss Cancer Institute at 21 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728663, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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