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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01500720
First received: December 22, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

  • To assess disease progression free rate at 12 weeks
  • To assess Response Rate (RECIST 1.1) and duration of response
  • To assess Overall Survival (OS)
  • To assess the Safety (NCI-CTC version 4.03)
  • To assess the Health-Related Quality of Life (HRQoL)

Condition Intervention Phase
Small Cell Lung Cancer
Drug: Cabazitaxel XRP6258
Drug: Topotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel
Cabazitaxel 25 mg/m² intravenously 1 hour (Day 1) every 3 weeks
Drug: Cabazitaxel XRP6258

Pharmaceutical form:solution

Route of administration: intravenous

Active Comparator: Topotecan
Topotecan 1.5 mg/m² intravenously 30 min (Day 1 to Day 5) every 3 weeks
Drug: Topotecan

Pharmaceutical form:solution

Route of administration: intravenous


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 allowed).
  • 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 randomization
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500720

  Show 58 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01500720     History of Changes
Other Study ID Numbers: ARD12166, 2011-003415-31, U1111-1123-3503
Study First Received: December 22, 2011
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014