Back to resultsA Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
Primary Purpose
Carcinoma, Small Cell
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Sagopilone (BAY86-5302, ZK 219477)
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Small Cell Lung Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sagopilone and cisplatin
Arm Description
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
Outcomes
Primary Outcome Measures
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
Phase 2: Efficacy measure
Secondary Outcome Measures
Phase 1: PK of Sagopilone + Cisplatin
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.
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00359359
Brief Title
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell
Keywords
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sagopilone and cisplatin
Arm Type
Experimental
Arm Description
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
Intervention Type
Drug
Intervention Name(s)
Sagopilone (BAY86-5302, ZK 219477)
Intervention Description
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
Primary Outcome Measure Information:
Title
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
Title
Phase 2: Efficacy measure
Time Frame
Phase 2: every 6 weeks after start of treatment
Secondary Outcome Measure Information:
Title
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
Title
Phase 2: Duration of CR or PR
Description
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
Title
Phase 2: TTP
Description
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
Title
Phase 2: PFS
Description
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
Title
Phase 2: OS
Description
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
Time Frame
every 3 months after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Gerlingen
State/Province
Baden-Württemberg
ZIP/Postal Code
70839
Country
Germany
City
Löwenstein
State/Province
Baden-Württemberg
ZIP/Postal Code
74245
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
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