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-naive patients with extensive-disease (ED) stage small-cell lung cancer (SCLC)
- Conditions
- Extensive disease (ED) stage small-cell lung cancer (SCLC)
- Registration Number
- EUCTR2006-000067-29-DE
- Lead Sponsor
- Bayer Schering Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
Patients must meet the following criteria to enroll in this study:
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. Adequate function of major organs and systems
• Hematopoietic:
- Hemoglobin >10 g/dL
- WBC:> 3.0 x 109/L
- Absolute neutrophil count: >1.5 x 109/L
- Platelet count: >100 x 109/L
• Hepatic:
- Total bilirubin: within normal range (< 1.5 times the upper limit of normal in
case of liver metastases)
- AST/ALT:< 2.5 times the upper limit of normal (< 5 times the upper limit of
normal in case of liver metastases)
• Renal:
- Creatinine: <1.5 times the upper limit of normal
- Creatinine clearance: > 60 ml/min
• Cardiovascular:No symptomatic congestive heart failure
- No unstable angina pectoris
- No myocardial infarction < 6 months prior to randomization
- No arrhythmia needing continuous treatment
• Nervous system:
- No Grade 2 or greater peripheral neuropathy
• Ear:
- No Grade 2 or greater hearing impairment
• No other uncontrolled concurrent illness
• No active infection
7. Survival expectation of at least three months
8. Negative pregnancy test at enrollment (females of childbearing potential only)
9. Agreement to use a highly effective method of birth control for adults of
reproductive potential
10. 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
Patients must not be enrolled if they meet any of the following criteria:
1. Prior chemotherapy for SCLC
2. Prior surgical resection for SCLC within 4 weeks prior to inclusion. Patient must
have recovered from all therapy related toxicities.
3. Prior radiotherapy for SCLC with the exception of radiation of brain metastases.
At least 3 weeks must have elapsed since radiotherapy and patient must have
recovered from all therapy related toxicities; the site of previous radiotherapy
should have evidence of progressive disease if it is the only site of disease.
4. Superior vena cava syndrome or obstruction of any vital structure
5. Untreated malignant hypercalcemia
6. Extensive disease amenable to radiation therapy
7. Symptomatic brain metastases requiring whole-brain irradiation (please note:
patients with brain metastases not requiring whole brain irradiation can be
enrolled)
8. History of another primary malignancy within the last 5 years with the exceptions
of non-melanoma skin cancer and carcinoma in situ of the cervix
9. Known allergy or hypersensitivity to platinum-containing drugs
10. Pregnant or breast-feeding women
11. Any condition that in the opinion of the investigator could hamper the compliance
with the study protocol
12. Use of any investigational drug within 4 weeks before start of study treatment
or inadequate recovery from any toxic effects of such therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method