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

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)

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Small Cell
• Intervention / Treatment: Drug: Sagopilone (BAY86-5302, ZK 219477); Drug: Cisplatin

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
  • Hamburg, Germany, 21075
  • Baden-Württemberg
    • Gerlingen, Baden-Württemberg, Germany, 70839
    • Löwenstein, Baden-Württemberg, Germany, 74245
  • Bayern
    • München, Bayern, Germany, 80336
    • München, Bayern, Germany, 81675
  • Hessen
    • Frankfurt, Hessen, Germany, 65929
    • Wiesbaden, Hessen, Germany, 65199
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin	Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure	Phase 2: every 6 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: PK of Sagopilone + Cisplatin		Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
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.	every 6 weeks after start of treatment
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.	every 6 weeks after start of treatment
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	every 6 weeks after start of treatment
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	every 3 months after start of treatment

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 27, 2006
• First Submitted That Met QC Criteria: August 1, 2006
• First Posted (Estimate): August 2, 2006

Study Record Updates

• Last Update Posted (Estimate): November 4, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Antineoplastic Agents; Cisplatin; Sagopilone
• Other Study ID Numbers: 91495; 2006-000067-29 (EudraCT Number); 310101 (Other Identifier: Company Internal)