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Clinical Trials/EUCTR2005-000597-53-DE
EUCTR2005-000597-53-DE
Active, not recruiting
Not Applicable

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)

Schering AG0 sitesOctober 31, 2005
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ConditionsExtensive disease (ED) stage small cell lung cancer (SCLC)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extensive disease (ED) stage small cell lung cancer (SCLC)
Sponsor
Schering AG
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 31, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Males or females aged \>\= 18 years
  • •2\. Histologically or cytologically proven SCLC
  • •3\. Stage of extensive disease defined by the presence of distant metastases
  • •4\. At least 1 unidimensionally measurable lesion (suitable for modRECIST
  • •evaluation)
  • •5\. WHO performance status 0 to 1
  • •6\. No previous SCLC\-related chemotherapy
  • •7\. No previous SCLC\-related surgery
  • •8\. No previous radiotherapy (excepting for brain metastases)
  • •9\. Adequate function of major organs and systems

Exclusion Criteria

  • •1\. Superior vena cava syndrom or obstruction of any vital structure
  • •2\. Untreated malignant hypercalcemia
  • •3\. Pleural effusion as the only manifestation of disease
  • •4\. Extensive disease amenable to radiation therapy
  • •5\. Symptomatic brain metastases requiring whole\-brain irradiation
  • •6\. Any concomitant malignancy excepting non\-melanoma skin cancer or carcinoma
  • •in situ of the cervix
  • •7\. Pregnant or breast\-feeding women
  • •8\. Any condition that in the opinion of the investigator could hamper the compliance
  • •with the study protocol

Outcomes

Primary Outcomes

Not specified

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