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Completed

NCT Number: NCT00359359

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

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

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Key information

Conditions

Carcinoma, Small Cell Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gerlingen, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sagopilone (BAY86-5302, ZK 219477)

Drug

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

Cisplatin

Drug

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

Primary outcomes

  1. 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

  2. Phase 2: Efficacy measure

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

Secondary outcomes

  1. 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

  2. Phase 2: Duration of CR or PR

    Time frame: every 6 weeks after start of treatment

    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.

  3. Phase 2: TTP

    Time frame: every 6 weeks after start of treatment

    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.

  4. Phase 2: PFS

    Time frame: every 6 weeks after start of treatment

    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

  5. Phase 2: OS

    Time frame: every 3 months after start of treatment

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 2, 2006
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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