Docetaxel - Carboplatin as Second Line Treatment in Patients With Small Cell Lung Cancer (DOCAR)
Recruitment status was: Recruiting
|First Received Date ICMJE||May 27, 2008|
|Last Updated Date||May 29, 2008|
|Start Date ICMJE||September 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Response rate [ Time Frame: 2 yrs ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Time to progression; Response duration; Survival; Safety profile [ Time Frame: 2 yrs ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Docetaxel - Carboplatin as Second Line Treatment in Patients With Small Cell Lung Cancer|
|Official Title ICMJE||A Phase II Study of Docetaxel - Carboplatin as Second Line Treatment in Patients With Refractory or Relapsed Small Cell Lung Cancer|
|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 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.|
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.
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.
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Small Cell Lung Cancer|
|Intervention ICMJE||Drug: Carboplatin, docetaxel
Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks
|Study Arms||Experimental: A
Intervention: Drug: Carboplatin, docetaxel
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||55|
|Estimated Completion Date||July 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Netherlands|
|Removed Location Countries|
|NCT Number ICMJE||NCT00686985|
|Other Study ID Numbers ICMJE||DOCAR study|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Dr. B. Biesma, Jeroen Bosch Ziekenhuis|
|Study Sponsor ICMJE||Jeroen Bosch Ziekenhuis|
|Collaborators ICMJE||Not Provided|
|PRS Account||Jeroen Bosch Ziekenhuis|
|Verification Date||May 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP