Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Phase 2TerminatedNCT00299390

Bayer10 enrolled

Overview

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell 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

Small Cell Lung Carcinoma

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically proven Small-cell lung cancer (SCLC) * Stage of extensive disease defined by the presence of distant metastases * At least 1 unidimensionally measureable lesion * WHO performance status 0 to 1 * No previous SCLC-related chemotherapy * No previous SCLC-related surgery * No previous radiotherapy (excepting for brain metastasis) * Adequate function of major organs and systems * Nervous system * No Grade 2 or greater peripheral neuropathy * Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No arrythmia needing continuous treatment * No other uncontrolled concurrent illness Exclusion Criteria: * Superior vena cava syndrome or obstruction of any vital structure * Untreated malignant hypercalcemia * Pleural effusion as the only manifestation of disease * Extensive disease amenable to radiation therapy * Symptomatic brain metastases requiring whole brain irradiation * Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Outcomes

Primary Outcomes

Response to treatment according to the modRECIST (complete response or partial response)

Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary Outcomes

Duration of complete or partial tumor response

Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Time to tumor progression

Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Number of participants with adverse events

Time frame: Approximately 30 weeks

Data from ClinicalTrials.gov

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