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Docetaxel and Cetuximab in Patients With Docetaxel-resistant Hormone-refractory Prostate Cancer (HRPC). A Multicenter Phase II Trial

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Docetaxel and Cetuximab in Patients With Docetaxel-resistant Hormone-refractory Prostate Cancer (HRPC). A Multicenter Phase II Trial


- 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

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

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- More than 2 weeks since prior radiotherapy

- More than 6 weeks since prior treatment with antiandrogens (i.e., flutamide or

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

at 12 weeks

Safety Issue:


Principal Investigator

Richard Cathomas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital Graubuenden


Switzerland: Swissmedic

Study ID:

SAKK 08/07



Start Date:

June 2008

Completion Date:

April 2010

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms