Docetaxel - Carboplatin as Second Line Treatment in Patients With Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeroen Bosch Ziekenhuis
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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