Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478502
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Jan Oldenburg, University Hospital, Akershus

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
Testicular Cancer Drug: cabazitaxel 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell
Study Start Date : June 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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 Name: Jevtana




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478502


Contacts
Layout table for location contacts
Contact: Jan Oldenburg, MD, PhD 91502900 ext +47 jan.oldenburg@medisin.uio.no
Contact: Lisbeth Johnsen, M.Sc 45246719 ext +47 lisbeth.johnsen@ahus.no

Locations
Layout table for location information
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Gedske Daugaard, MD, PhD    35453545 ext +45    gedske.daugaard@rh.regionh.dk   
Principal Investigator: Gedske Daugaard, MD, PhD         
Germany
University Clinic Hamburg Eppendorf Withdrawn
Hamburg, Germany, 20246
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T) Active, not recruiting
Meldola, Italy, 47014
Norway
Oslo University Hospital Recruiting
Oslo, Norway, N-0424
Contact: Helene Negaard, MD, PhD       UXHEGA@ous-hf.no   
Contact: Marit Husby, MD    23026600 ext +47    UXHUMC@ous-hf.no   
Principal Investigator: Helene Negaard, MD, PhD         
Sweden
University Hospital of Uppsala, Department of Oncology Active, not recruiting
Uppsala, Sweden, 75185
Sponsors and Collaborators
University Hospital, Akershus
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: Jan Oldenburg, MD, PhD University Hospital, Akershus

Layout table for additonal information
Responsible Party: Jan Oldenburg, MD, PhD, Coordinating Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02478502    
Other Study ID Numbers: 2012/1627 b
2012-004418-32 ( EudraCT Number )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Jan Oldenburg, University Hospital, Akershus:
testicular cancer
cisplatin resistancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Cisplatin
Antineoplastic Agents