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A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

Disease evaluation at Week 6

Safety Issue:


Principal Investigator

Athanasio Kotsakis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Herklion


Greece: National Organization of Medicines

Study ID:




Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

  • Metastatic NSCLC
  • 2nd Line
  • Docetaxel-based treatment
  • Progressed
  • Refractory
  • Carcinoma, Non-Small-Cell Lung