Testis CAB: Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell Cancer

University Hospital, Akershus (Other)
Overall Status
CT.gov ID
Sanofi (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Patients with metastatic germ cell cancer and relapse after two or more courses of cisplatin-based chemotherapy or after high-dose chemotherapy have a poor prognosis and no curative options. Taxanes in various combinations unfold cytotoxic effects on germ cell tumors resistant to conventional doses of cisplatin. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. In most patients, however, resistance to paclitaxel, as evidenced by progression occurs.Cabazitaxel has been developed to overcome resistance to docetaxel and paclitaxel. It has shown efficacy in patients progressing during docetaxel therapy in a large phase III trial (TROPIC) in patients with castration-resistant prostate cancer. Furthermore, chemotherapy resistance might be less likely to develop in patients receiving cabazitaxel as compared to other taxanes.

Study Design

Study Type:
Anticipated Enrollment :
29 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cabazitaxel (single arm study)

Cabazitaxel 25 mg/m2 each 3. week (no other drugs will be administered)

Drug: cabazitaxel
cabazitaxel is given to patients with progressive testicular cancer after cisplatin-based chemotherapy
Other Names:
  • Jevtana
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [after 3 and 6 cycles of cabazitaxel (9 and 18 weeks, respectively) as change from baseline (radiologic evaluation before first cycle of cabazitaxel)]

      Recist 1.1

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Systemic antitumor treatment within 21 days before study entry

    • Simultaneous radiotherapy to the only target lesion

    • Patients unwilling or unable to comply with the protocol

    • Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure New York Heart Association (NYHA) III-IV or serious uncontrolled cardiac arrhythmias

    • Patients with an active or uncontrolled infection

    • Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer

    • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks

    • Patients who have participated in another interventional clinical trial within 30 days before study entry

    • Other serious medical conditions that could impair the ability of the patient to participate in the study

    • Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication

    • Neuropathy ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)

    • Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel

    • One or more of the following cabazitaxel-specific requirements:

    • History of severe hypersensitivity reaction (≥ Grade 3) to docetaxel

    • History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs

    • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4) (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)

    • Concurrent or planned treatment with Organic anion transporting polypeptide1B1 (OATP1B1) substrates e.g. statins, valsartan, repaglinide which have to be taken within 12 hours before cabazitaxel application and 3 hours after the end of infusion, refer table 9

    Contacts and Locations


    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark
    2 University Clinic Hamburg Eppendorf Hamburg Germany 20246
    3 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T) Meldola Italy 47014
    4 Oslo University Hospital Oslo Norway N-0424
    5 University Hospital of Uppsala, Department of Oncology Uppsala Sweden 75185

    Sponsors and Collaborators

    • University Hospital, Akershus
    • Sanofi


    • Principal Investigator: Jan Oldenburg, MD, PhD, University Hospital, Akershus

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Jan Oldenburg, MD, PhD, Coordinating Investigator, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 2012/1627 b
    • 2012-004418-32
    First Posted:
    Jun 23, 2015
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Jan Oldenburg, MD, PhD, Coordinating Investigator, University Hospital, Akershus
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022