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

NCT02478502 | Terminated Phase 2 DMC

• 2 other identifiers: 2012/1627 b2012-004418-32
• Study Type: interventional
• Target: 14
• Locations: 4 countries
• Sites: 4

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.

Conditions

Testicular Cancer

Keywords

testicular cancer; cisplatin resistancy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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)

Study Arms (1)

Cabazitaxel (single arm study)

EXPERIMENTAL

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

Drug: cabazitaxel

Interventions

cabazitaxel DRUG

cabazitaxel is given to patients with progressive testicular cancer after cisplatin-based chemotherapy

Also known as: Jevtana

Cabazitaxel (single arm study)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Sanofi: collaborator

Study Sites (4)

Rigshospitalet

Copenhagen, Denmark

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)

Meldola, 47014, Italy

Location

Oslo University Hospital

Oslo, N-0424, Norway

Location

University Hospital of Uppsala, Department of Oncology

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Jan Oldenburg, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Coordinating Investigator

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

IT (1); DK (1); SE (1); NO (1)