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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-08-07 | |||
| MERCK-SAKK-0807 | |||
| SANOFI-AVENTIS-SWS-SAKK-0807 | |||
| CDR0000599858 |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 --- |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 --- |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | at 12 weeks | |
| Progression-free survival (PFS) | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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
No presence or history of CNS metastases
PATIENT CHARACTERISTICS:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonspital Aarau | Aarau | CH-5001 | Switzerland | |||
| Kantonsspital Baden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 22977195 | 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. |
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| 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 --- |
|
|
| 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. |
| Baden |
| CH-5404 |
| Switzerland |
| Saint Claraspital AG | Basel | CH-4016 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Spitalzentrum Biel | Biel | CH-2501 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| AndreasKlinik Cham Zug | Cham | CH-6330 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Kantonsspital Freiburg | Fribourg | 1708 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital Liestal | Liestal | CH-4410 | Switzerland |
| Kantonsspital, Luzerne | Luzerne | CH-6000 | Switzerland |
| Kantonsspital Olten | Olten | CH-4600 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| Onkozentrum | Zurich | 8038 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8032 | Switzerland |
| City Hospital Triemli | Zurich | CH-8063 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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