Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728663
• Other study ID #: SAKK 08/07
• Secondary ID: SWS-SAKK-08-07ME
• Status: Completed
• Phase: Phase 2
• Start date: June 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2014
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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 ---

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 ---

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Saint Claraspital AG	Basel
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Spitalzentrum Biel	Biel
Switzerland	Kantonsspital Bruderholz	Bruderholz
Switzerland	AndreasKlinik Cham Zug	Cham
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Kantonsspital Freiburg	Freiburg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital Liestal	Liestal
Switzerland	Kantonsspital, Luzerne	Luzerne
Switzerland	Kantonsspital Olten	Olten
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	Regionalspital	Thun
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich
Switzerland	Onkozentrum	Zurich
Switzerland	UniversitaetsSpital Zuerich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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 — View Citation

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 On

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		at 12 weeks
Primary	Progression-free survival (PFS)		at 24 weeks
Secondary	Adverse events		All AEs will be assessed according to NCI CTCAE v3.0.
Secondary	Prostate-specific antigen (PSA) response (30% and 50% PSA response)		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)
Secondary	Tumor assessment of measurable disease according to RECIST criteria		after 12 weeks of treatment, or earlier if clinically indicated
Secondary	Tumor assessment of bone lesions		at 12 weeks
Secondary	Overall survival		calculated from registration until death.