Clinical trial · Interventional

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

NCT00299390CI-TRIAL-00020394terminatedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .

Summary

Brief summary (as posted)

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Small Cell Lung Carcinoma	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Sagopilone (BAY86-5302, ZK 219477)	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Sagopilone
interventionNames
1. Drug: Sagopilone (BAY86-5302, ZK 219477)

Primary outcomes (1)

measure
Response to treatment according to the modRECIST (complete response or partial response)
timeFrame
Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary outcomes (3)

measure
Duration of complete or partial tumor response
timeFrame
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
measure
Time to tumor progression
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically or cytologically proven Small-cell lung cancer (SCLC)
* Stage of extensive disease defined by the presence of distant metastases
* At least 1 unidimensionally measureable lesion
* WHO performance status 0 to 1
* No previous SCLC-related chemotherapy
* No previous SCLC-related surgery
* No previous radiotherapy (excepting for brain metastasis)
* Adequate function of major organs and systems

  * Nervous system

    * No Grade 2 or greater peripheral neuropathy
  * Cardiovascular:

    * No symptomatic congestive heart failure
    * No unstable angina pectoris
    * No arrythmia needing continuous treatment
    * No other uncontrolled concurrent illness

Exclusion Criteria:

* Superior vena cava syndrome or obstruction of any vital structure
* Untreated malignant hypercalcemia
* Pleural effusion as the only manifestation of disease
* Extensive disease amenable to radiation therapy
* Symptomatic brain metastases requiring whole brain irradiation
* Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

References

Publications (0)

Data not yet available

No reference posted for this study.