A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

Bayer26 enrolled

Overview

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Small Cell

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

CisplatinDRUG

75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Small-cell lung cancer * Stage of extensive disease * Adequate function of major organs and systems * Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: * Prior chemotherapy for small-cell lung cancer * Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases * Superior vena cava syndrome or obstruction of any vital structure * Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation * Known allergy or hypersensitivity to platinum-containing drugs * Pregnancy or breast-feeding * Use of any investigational drug within 4 weeks before start of the study

Locations (10)

Unnamed facility

Gerlingen, Baden-Wurttemberg, Germany

Unnamed facility

Löwenstein, Baden-Wurttemberg, Germany

Unnamed facility

München, Bavaria, Germany

Unnamed facility

München, Bavaria, Germany

Outcomes

Primary Outcomes

Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin

Time frame: Phase 1: Baseline up to 3 month of treatment

Phase 2: Efficacy measure

Time frame: Phase 2: every 6 weeks after start of treatment

Secondary Outcomes

Phase 1: PK of Sagopilone + Cisplatin

Time frame: Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion

Phase 2: Duration of CR or PR

Duration of complete response (CR) or partial response (PR) as 'overall response', defined as time between first date that the measurement criteria for CR or PR as 'overall response' are met and first date that recurrence or overall response of (progressive disease) PD is documented.

Time frame: every 6 weeks after start of treatment

Phase 2: TTP

Time to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment.

Time frame: every 6 weeks after start of treatment

Phase 2: PFS

Progression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessment

Time frame: every 6 weeks after start of treatment

Phase 2: OS

Overall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alive

Data from ClinicalTrials.gov

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