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

February 1, 2024 updated by: Jan Oldenburg, University Hospital, Akershus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • Italy
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)
  • Norway
      • Oslo, Norway, N-0424
        • Oslo University Hospital
  • Sweden
      • Uppsala, Sweden, 75185
        • University Hospital of Uppsala, Department of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 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
after 3 and 6 cycles of cabazitaxel (9 and 18 weeks, respectively) as change from baseline (radiologic evaluation before first cycle of cabazitaxel)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

Sanofi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimated)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1627 b
  • 2012-004418-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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