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Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Patients will be treated until progressive disease, unacceptable toxicity or refusal for
further study treatment.

All patients will be followed for disease progression documentation and for patient status
until the study cut-off date

Inclusion Criteria

Inclusion criteria :

- Histological/cytological proven locally advanced or metastatic small cell lung cancer
with progressive disease during or after first line platinum based chemotherapy

- Male or female ≥18 years (or country's legal age of majority if >18 years)

- Patients with measurable disease, RECIST (version 1.1)

- ECOG performance status ≤1

Exclusion criteria:

- Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.

- More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes.

- Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or
surgery to the time of randomization. (Radiotherapy for bone pain palliation is

- Adverse events (excluding alopecia) from any prior anticancer therapy of grade
>1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the
time of randomization.

- Uncontrolled CNS metastases: patients with CNS metastases may have previous
irradiation, only patients with SD or response to irradiation who are without CNS
symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent can
be included.

- Patients with known leptomeningeal metastases

- History of other, invasive neoplasm requiring ongoing therapy.

- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization

- Any of the following within 6 months prior to study enrollment: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.

- Any severe acute or chronic medical condition, which could impair the ability of the
patient to participate in the study or interfere with interpretation of study results

- Known HIV disease, or active hepatitis B or C (systematic testing is not required).

- Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to

- Patient with reproductive potential (M/F) who do not agree to use an accepted and
effective method of contraception during the study treatment period and for at least
6 months after the completion of the study treatment. The definition of "effective
method of contraception" will be based on the investigator's judgment. Effective
method of contraception should also be adapted to local regulation.

- History of hypersensitivity to polysorbate 80

- Inadequate organ and bone marrow function as evidenced by:

- Hemoglobin <9.0 g/dL

- Absolute neutrophil count <1.5 x 109/L

- Platelet count <100 x 109/L

- AST/SGOT and/or ALT/SGPT >2.5 x ULN

- AP >2.5 x ULN. In case of liver metastases AP > 5 x ULN

- Total bilirubin >1.0 x ULN

- 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 creatinine clearance <60
mL/min will exclude the patient.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

up to 24 months

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

October 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Investigational Site Number 840001Philadelphia, Pennsylvania  19111
Investigational Site Number 840007Muscle Shoals, Alabama  35661
Investigational Site Number 840006Lebanon, New Hampshire  03756
Investigational Site Number 840003Middletown, Ohio  45042
Investigational Site Number 840005Omaha, Nebraska  68114
Investigational Site Number 840101Philadelphia, Pennsylvania  19104
Investigational Site Number 840004Salt Lake City, Utah  84112-5550