Status:
COMPLETED
Docetaxel - Carboplatin As Second Line Treatment in Patients with Small Cell Lung Cancer
Lead Sponsor:
Dr. B. Biesma
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Phase II studies with docetaxel in first line - and second line treatment of SCLC demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel seems suitable for evaluat...
Detailed Description
Background: Small cell lung cancer (SCLC) is diagnosed in approximately 15 % of all the lung cancer cases. SCLC is recognized by its rapid tumor growth, with a high chemo- and radio sensitivity, and ...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven SCLC at the first diagnosis
- Refractory or relapsed SCLC
- Measurable disease according to RECIST criteria
- There must be a minimum of 2 weeks between the end of prior radiotherapy and study entry. (No more than 30% of available bone marrow should have been irradiated as recommended by the RTOG).
- Patients must have fully recovered from toxic effects of previous antitumor therapy.
- Age \> 18 years.
- WHO performance status 0- 2 (Appendix II).
- Hb \> 6.0 mmol/L,
- Neutrophils \> 1.5 x 109/L,
- Platelets \> 100 x 109/L·
- Total bilirubin \< the upper-normal limits of the institutional normal values.
- ALAT (SGPT), ASAT (SGOT) \< 2.5 times the upper-normal limits of the institutional normal values.
- Alkaline Phosphatase \< 5 times the upper-normal limits of the institutional normal values. If AP \> 2.5 x ULN then ALAT and ASAT must be \<1.5 x ULN, otherwise, the patient is not eligible
- Creatinine \< 140 mmol/L; or creatinine clearance according to Cockcroft formula \>50 ml/min·
- Signed informed consent prior to beginning protocol specific procedures
Exclusion
- More than one line of chemotherapy for metastatic disease
- Treatment with a platinum compound during the last 3 months before randomisation
- Pregnant or lactating women or women of childbearing potential not adhering to adequate anticonceptive measures
- Evidence of (other) active invasive malignancy other than non-melanoma skin cancer.
- Clinical evidence CNS metastases.
- Symptomatic peripheral neuropathy \> grade 2 according (NCI CTC, Appendix III)Definite contraindications for the use of corticosteroids
- Concurrent treatment with other experimental drugs.
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Concurrent treatment with any other cytotoxic anti-cancer therapy
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00686985
Start Date
September 1 2007
End Date
July 1 2012
Last Update
September 20 2024
Active Locations (1)
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1
B. Biesma
's-Hertogenbosch, North Brabant, Netherlands, 5211NL