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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Topotecan

Drug: Cabazitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01500720

U1111-1123-3503 (Other Identifier)

ARD12166

2011-003415-31 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants 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 (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
To assess Overall Survival (OS)
To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
To assess the Health-Related Quality of Life (HRQoL)

Full description

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Enrollment

179 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

Absence of signed and dated Institutional Review Board (IRB)-approved participant 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 Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
Participants 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, New York Heart Association 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 participant to participate in the study or interfere with interpretation of study results
Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
Participant with reproductive potential (M/F) who did 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" was 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 less than [<] 9.0 gram per deciliter (g/dL)
- Absolute neutrophil count <1.5 x 10^9 per liter
- Platelet count <100 x 10^9 per liter
- Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
- Alkaline Phosphatase (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 Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.