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

• ClinicalTrials.gov Identifier: NCT00359359
• Recruitment Status: Completed
• First Posted: August 2, 2006
• Last Update Posted: November 4, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

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

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00359359
• Other Study ID Numbers: 91495; 2006-000067-29 ( EudraCT Number ); 310101 ( Other Identifier: Company Internal )
• First Posted: August 2, 2006
• Last Update Posted: November 4, 2014
• Last Verified: November 2014

Keywords provided by Bayer:

Small Cell Lung Cancer

Additional relevant MeSH terms:

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