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)

• Conditions: Extensive disease (ED) stage small cell lung cancer (SCLC)

• Registration Number: EUCTR2005-000597-53-DE
• Lead Sponsor: Schering AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
• Nervous system:
- No Grade 2 or greater peripheral neuropathy
• Hematopoietic:
- Hemoglobin: >= 10 g/dL
- WBC: >= 3,000/mm3
- Absolute neutrophil count: >= 1,500/mm3
- Platelet count: >= 100,000/mm3
• Hepatic:
- Total bilirubin: normal
- AST/ALT: <= 2.5 times the upper limit of normal
• Renal: -Creatinine: <= 2 mg/dL
• Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No arrhythmia needing continuous treatment
• No other uncontrolled concurrent illness

10. Negative pregnancy test at enrollment (females of childbearing potential only)

11. Agreement to use highly effective contraception methods (intra-uterine
contraceptive device IUCD, condoms, oral contraceptives, or other adequate
barrier contraception) in females of child-bearing potential

12. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified