2nd line treatment with cabazitaxel in patients with NSCLC

Active, not recruiting

• Conditions: Patients with stage IIIB with pleural effusion or stage IV NSCLC with documented disease progression during or after completion of docetaxel-based treatment are eligible for the study.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000275-16-GR
• Lead Sponsor: Hellenic Oncology Research Group (H.O.R.G.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-08
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age>18 years old
-Cytologically or histologically documented NSCLC
-PS 0-2 (WHO scale)
-Measurable disease according to RECIST v1.1 (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 (RECIST v.1.1) 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.[18]
-Performance status 0-2 (WHO scale)
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified