Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell

Who is this study for? Adult male patients with testicular cancer
What treatments are being studied? Cabazitaxel
Status: Terminated
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical activity in patients with metastatic and progressive germ cell tumors.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male patients ≥ 18 years old

• Histologically verified metastatic germ cell cancer (GCC) of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum

• Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2

• Life expectancy ≥ 3 months

• At baseline adequate function of liver, kidneys and bone marrow:

⁃ ·Neutrophils ≥ 1.5 x 109/L·

• Hemoglobin ≥ 9.0 g/dL

• Platelets ≥ 100 x 109/L

• Creatinine ≤ 1.5 x upper limit of normal (ULN)

• Total Bilirubin ≤ 1.0 x ULN

• Serum glutamate oxaloacetate transaminase (SGOT/AST) ≤ 1.5 x ULN

• Serum glutamate pyruvate transaminase (SGPT/ALT) \< 1.5 x ULN

Locations
Other Locations
Denmark
Rigshospitalet
Copenhagen
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)
Meldola
Norway
Oslo University Hospital
Oslo
Sweden
University Hospital of Uppsala, Department of Oncology
Uppsala
Time Frame
Start Date: 2015-06
Completion Date: 2022-12-31
Participants
Target number of participants: 14
Treatments
Experimental: Cabazitaxel (single arm study)
Cabazitaxel 25 mg/m2 each 3. week (no other drugs will be administered)
Related Therapeutic Areas
Sponsors
Collaborators: Sanofi
Leads: University Hospital, Akershus

This content was sourced from clinicaltrials.gov

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