Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00728663

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-04-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 ---

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

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 ---

docetaxel

Intervention Type: DRUG

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

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 ---

Intervention Type: BIOLOGICAL

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 ---

Intervention Type: DRUG

Other Intervention Names

Erbitux; Taxotere

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Cathomas, MD

Role: STUDY_CHAIR

Kantonsspital Graubuenden

Roger von Moos, MD

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Graubuenden

Silke Gillessen, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital of St. Gallen

Locations

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

Fribourg, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital Liestal

Liestal, , Switzerland

Kantonsspital, Luzerne

Luzerne, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Regionalspital

Thun, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Onkozentrum

Zurich, , Switzerland

Klinik Hirslanden

Zurich, , Switzerland

City Hospital Triemli

Zurich, , Switzerland

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 22977195 (View on PubMed)

Other Identifiers

SWS-SAKK-08-07

Identifier Type: -

Identifier Source: secondary_id

MERCK-SAKK-0807

Identifier Type: -

Identifier Source: secondary_id

SANOFI-AVENTIS-SWS-SAKK-0807

Identifier Type: -

Identifier Source: secondary_id

CDR0000599858

Identifier Type: -

Identifier Source: secondary_id

SAKK 08/07

Identifier Type: -

Identifier Source: org_study_id