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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00359359
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Small Cell Drug: Sagopilone (BAY86-5302, ZK 219477) Drug: Cisplatin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00359359

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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
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00359359    
Other Study ID Numbers: 91495
2006-000067-29 ( EudraCT Number )
310101 ( Other Identifier: Company Internal )
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Bayer:
Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents