Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

NCT00728663 | Completed Phase 2

• 5 other identifiers: SAKK 08/07SWS-SAKK-08-07MERCK-SAKK-0807SANOFI-AVENTIS-SWS-SAKK-0807CDR0000599858
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 21

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  at 12 weeks

• Progression-free survival (PFS)

  at 24 weeks

Secondary Outcomes (5)

• Adverse events

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

• 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)

• Tumor assessment of measurable disease according to RECIST criteria

  after 12 weeks of treatment, or earlier if clinically indicated

• Tumor assessment of bone lesions

  at 12 weeks

• Overall survival

  calculated from registration until death.

Study Arms (1)

Arm: Cetuximab and Docetaxel

EXPERIMENTAL

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 ---

Biological: cetuximab; Drug: docetaxel

Interventions

cetuximab 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 ---

Also known as: Erbitux

Arm: Cetuximab and Docetaxel

docetaxel 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 ---

Also known as: Taxotere

Arm: Cetuximab and Docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (21)

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

AndreasKlinik Cham Zug

Cham, CH-6330, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Kantonsspital Freiburg

Fribourg, 1708, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Kantonsspital, Luzerne

Luzerne, CH-6000, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Onkozentrum

Zurich, 8038, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (2)

• 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.

  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.

  PMID: 22977195 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cetuximab; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Richard Cathomas, MD

  Kantonsspital Graubuenden

  STUDY CHAIR

• Roger von Moos, MD

  Kantonsspital Graubuenden

  PRINCIPAL INVESTIGATOR

• Silke Gillessen, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 6, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2010
• Last Updated: May 14, 2019

Record last verified: 2014-04

Locations

CH (21)