Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of Docetaxel - Carboplatin as Second Line Treatment in Patients With Refractory or Relapsed Small Cell Lung Cancer
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 evaluation in combination with other cytotoxic drugs active in this disease. A phase II study in previously untreated patients with SCLC shows that the combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in extensive SCLC.
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 by its high metastasizing potential. Patients with extensive-stage disease
have a 5-year survival rate of 1% to 2%.
Almost 2/3 of the patients have already extensive disease (ED) upon diagnosis.The
recommended treatment of ED-SCLC is systemic chemotherapy, considered to be the standard
first line treatment option in all patients with SCLC regardless of performance status and
age. World-wide, the most commonly used regimen for 1st line treatment is the combination of
cisplatin-etoposide, while in the Netherlands the cyclophosphamide, doxorubicin and
etoposide regimen is widely used.Survival outcome with these regimens appear similar.
Unfortunately, relapses occur in all patients and responses to second-line chemotherapy have
proven to be of short term. Until recently, there were no registered drugs for treatment of
relapsing SCLC. 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 evaluation in combination with other cytotoxic drugs active in
this disease. Until now no studies have been performed with a combination of docetaxel and
platinum in this group of previously treated SCLC patients.
A phase II study in previously untreated patients with SCLC shows that the combination
docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in extensive
SCLC.
Study objectives:
To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with
refractory or relapsed SCLC. Furthermore to asses the safety profile of the
docetaxel/carboplatin combination.
Trial design:
This study will be a open label non-randomized study conducted in patients with refractory
or relapsed SCLC. It is a phase II study with 50 patients.
Docetaxel infusion 75 mg/m2, carboplatin AUC = 6 mg/ml·min day 1, every 21 days for 4-6
cycles.
Population:
Patients with histologically or cytologically proven SCLC at the first diagnosis with
refractory or relapsed SCLC after first line treatment. Signed informed consent. Age > 18
years. WHO ps 0,1 or 2.
Endpoints:
Primary endpoint: response rate. Secondary endpoint(s): time to progression, response
duration, safety profile and survival.
Stress and risks for the patient:
Hospital visits and tests are not different from the standard treatment. Stress due to
adverse events is not essential higher estimated. Special risks are not expected. Frequently
medical examination and control of laboratory results will be done. Detailed instruction
will be given about what do to in case of serious toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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