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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00359359
First received: July 27, 2006
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Carcinoma, Small Cell
Drug: Sagopilone (BAY86-5302, ZK 219477)
Drug: Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Phase 2: Efficacy measure [ Time Frame: Phase 2: every 6 weeks after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Phase 2: Duration of CR or PR [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: No ]
    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.

  • Phase 2: TTP [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: No ]
    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.

  • Phase 2: PFS [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: No ]
    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

  • Phase 2: OS [ Time Frame: every 3 months after start of treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 26
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sagopilone and cisplatin
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
Drug: Sagopilone (BAY86-5302, ZK 219477)
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
Drug: Cisplatin
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00359359

Locations
Germany
Gerlingen, Baden-Württemberg, Germany, 70839
Löwenstein, Baden-Württemberg, Germany, 74245
München, Bayern, Germany, 80336
München, Bayern, Germany, 81675
Frankfurt, Hessen, Germany, 65929
Wiesbaden, Hessen, Germany, 65199
Essen, Nordrhein-Westfalen, Germany, 45147
Mainz, Rheinland-Pfalz, Germany, 55131
Berlin, Germany, 12200
Hamburg, Germany, 21075
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00359359     History of Changes
Other Study ID Numbers: 91495, 2006-000067-29, 310101
Study First Received: July 27, 2006
Last Updated: November 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Small Cell
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014