Clinical trial NCT00359359: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Small Cell
Keywords: Small Cell Lung Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
timeFrame: Phase 1: Baseline up to 3 month of treatment
measure: Phase 2: Efficacy measure
timeFrame: Phase 2: every 6 weeks after start of treatment
Secondary outcomes:
measure: Phase 1: PK of Sagopilone + Cisplatin
timeFrame: Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
measure: Phase 2: Duration of CR or PR
timeFrame: every 6 weeks after start of treatment
measure: Phase 2: TTP
timeFrame: every 6 weeks after start of treatment
measure: Phase 2: PFS
timeFrame: every 6 weeks after start of treatment
measure: Phase 2: OS
timeFrame: every 3 months after start of treatment
Other outcomes:
Locations:
city: Gerlingen
country: Germany
state: Baden-Württemberg
city: Löwenstein
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Wiesbaden
country: Germany
state: Hessen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Berlin
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: