Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer
- Registration Number
- NCT00728663
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm: Cetuximab and Docetaxel cetuximab 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 --- Arm: Cetuximab and Docetaxel 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 ---
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) at 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse events All AEs will be assessed according to NCI CTCAE v3.0. Tumor assessment of bone lesions at 12 weeks Overall survival calculated from registration until death. Tumor assessment of measurable disease according to RECIST criteria after 12 weeks of treatment, or earlier if clinically indicated 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)
Trial Locations
- Locations (21)
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
AndreasKlinik Cham Zug
🇨ðŸ‡Cham, Switzerland
Spitalzentrum Biel
🇨ðŸ‡Biel, Switzerland
Kantonsspital Winterthur
🇨ðŸ‡Winterthur, Switzerland
Kantonsspital Baden
🇨ðŸ‡Baden, Switzerland
Kantonsspital Bruderholz
🇨ðŸ‡Bruderholz, Switzerland
Kantonsspital Graubuenden
🇨ðŸ‡Chur, Switzerland
Saint Claraspital AG
🇨ðŸ‡Basel, Switzerland
Universitaetsspital-Basel
🇨ðŸ‡Basel, Switzerland
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Kantonsspital Liestal
🇨ðŸ‡Liestal, Switzerland
Onkozentrum
🇨ðŸ‡Zurich, Switzerland
Klinik Hirslanden
🇨ðŸ‡Zurich, Switzerland
Kantonsspital Freiburg
🇨ðŸ‡Freiburg, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Kantonsspital Olten
🇨ðŸ‡Olten, Switzerland
Kantonsspital, Luzerne
🇨ðŸ‡Luzerne, Switzerland
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
City Hospital Triemli
🇨ðŸ‡Zurich, Switzerland
UniversitaetsSpital Zuerich
🇨ðŸ‡Zurich, Switzerland