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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00359359

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

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 :

Jul 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Aug 1, 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

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

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

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 [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.
Phase 2: TTP [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.
Phase 2: PFS [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
Phase 2: OS [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	City	State	Country	Postal Code
1	Gerlingen	Baden-Württemberg	Germany	70839
2	Löwenstein	Baden-Württemberg	Germany	74245
3	München	Bayern	Germany	80336
4	München	Bayern	Germany	81675
5	Frankfurt	Hessen	Germany	65929
6	Wiesbaden	Hessen	Germany	65199
7	Essen	Nordrhein-Westfalen	Germany	45147
8	Mainz	Rheinland-Pfalz	Germany	55131
9	Berlin		Germany	12200
10	Hamburg		Germany	21075