- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01852578
Cabazitaxel in Relapsed and Metastatic NSCLC
A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment
Study Overview
Detailed Description
Non small cell lung cancer represents the second most common type of cancer in both men and women in the Western world. The availability of new active regimens in the first line setting has prompted several investigators to consider second line therapy for patients with advanced NSCLC, since a substantial percentage of patients maintain a good PS upon recurrence. On the basis of the results of phase III trials docetaxel, erlotinib, gefitinib, or pemetrexed are considered as "standard" choices for second-line therapy.
However, despite the increased availability of different drugs, NSCLC remains a devastating disease with median OS which rarely exceeds 12 months.
Preclinical data of cabazitaxel have demonstrated antitumor activity in models resistant to paclitaxel and docetaxel. In cell lines resistant to cytotoxic agents, cabazitaxel induced further tumor regression.
The recommended phase 2 doses for Cabazitaxle were 20 and 25 mg/m2. Cabazitaxel showed antitumor activity in solid tumors including docetaxel-refractory metastatic castration-resistant prostate cancer and breast cancer.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Athens, Greece
- Air Forces Military Hospital of Athens Athens, Greece
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Athens, Greece
- "IASO" General Hospital of Athens Athens, Greece
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Thessaloniki, Greece
- "PAPAGEORGIOY" General Hospital of Thessaloniki
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Crete
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Chania, Crete, Greece
- "Ag. Georgios" General Hospital of Chania
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Heraklion, Crete, Greece
- University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age>18 years old
- Cytologically or histologically documented NSCLC
- PS 0-2 (WHO scale)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
- Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors with at least one visceral or soft-tissue metastatic lesion.
- Brain metastases are allowed, given that are clinically stable and the patient does not present neurologic symptoms.
- Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields. Patients who were irradiated to ≥ 40% of bone marrow are not eligible for the study.
- Patients must have a recent (within 7 days prior to treatment start) biochemical and hematogical assessment as defined by adequate bone marrow (absolute neutrophil count ≥1.5 x 109 cells/L, platelets ≥100 x 109cells/L and hemoglobin ≥9 g/dL), liver (AST & ALT ≤ 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine < 1.5 x ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded) function tests
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Before patient enrollment, written informed consent must be given according to ICH/GCP and national/local regulations.
Exclusion Criteria:
- Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy.
- Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial.
- Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix.
- Patient with reproductive potential not implementing accepted and effective method of contraception
- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs or to docetaxel
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus, hypertension, heart failure ≤ NYHA II, history of myocardial infarction within the past 6 months, angina, chronic obstructive pulmonary disease (COPD), serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral)
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
- Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment
- Active grade ≥2 peripheral neuropathy
- Active grade ≥2 stomatitis
Study Plan
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: 1
|
Cabazitaxel: 25 mg/m² i.v over 1 h on day 1.
Cycles repeated ever 3 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Response Rate
Time Frame: Disease evaluation at Week 6
|
Disease evaluation at Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 1 year
|
1 year
|
|
Progression Free Survival
Time Frame: 1 year
|
1 year
|
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Disease control rate
Time Frame: Disease evaluation at Week 6
|
Disease control rate is defined as the proportion of patients with complete response plus partial response plus stable disease
|
Disease evaluation at Week 6
|
Toxicity profile
Time Frame: Every 3 weeks
|
Every 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Athanasio Kotsakis, MD, University Hospital of Herklion
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/12.02
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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