Carcinoma, Small Cell
Conditions
Keywords
Small Cell Lung Cancer
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.
Interventions
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
DRUGCisplatin
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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: 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 |
| 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: 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. |
Countries
Germany
Outcome results
None listed