|- candidate number||2525|
|- NTR Number||NTR937|
|- Date ISRCTN created||11-apr-2007|
|- date ISRCTN requested||24-mrt-2007|
|- Date Registered NTR||20-mrt-2007|
|- Secondary IDs|| |
|- Public Title||Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC).|
|- Scientific Title||Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC).|
|- hypothesis||The aim of the study is to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC as a once every three weeks schedule.|
|- Healt Condition(s) or Problem(s) studied||Small cell lung cancer (SCLC)|
|- Inclusion criteria||1. Cytologically or histologically proven SCLC; |
2. Disease confined to one hemithorax without evidence of cytologically proven malignant pleural effusion;
3. No prior chemotherapy and/or radiotherapy;
4. Age 18 years or older;
5. Performance score 0 or 1;
6. Adequate organ functions (WBC > 3.0 x 10^9/L, ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L, serum creatinine < 135 mmol/L or creatinine clearance according to Cockroft-Gault formula > 60 ml/min, bilirubin < 1.25 ULN, AST/ALT < 2.5 ULN and LDH < 1.25 ULN);
7. Adequate pulmonary function (FEV1 > 30% of predicted, DLCO > 40% of predicted);
8. No prior malignancy unless 5 years in complete remission except for patients with prior breast cancer or melanoma. Patients with adequately treated basocellular carcinoma of the skin or cervical cancer are eligible;
9. Written informed consent.
|- Exclusion criteria||1. Other serious ilnesses;|
2. Concurrent therapy with other anti-cancer drugs;
3. Pregnancy or lactation;
4. Presence of diarrhoea;
5. Presence of suspicion of bowel obstruction or chronic inflammatory bowel disease.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||6-jan-2003|
|- planned closingdate||1-jan-2006|
|- Target number of participants||9|
|- Interventions||Patients were treated at day 1 of three-weekly cycles 1 and 4 with irinotecan and cisplatin (340 mg and 135 mg, respectively).|
A dose-escalation schedule of irinotecan (100/120/140/150 mg) and cisplatin (100 mg) at day 1 of cycles 2 and 3 with concurrent thoracic radiotherapy (total dose 45 Gy) was performed. At each dose level 3 patients were included.
Dose-limiting toxicity (DLT) was defined as one patient in any cohort having any of the following toxicities during cycle 2 and 3 (with concurrent thoracic radiotherapy), grade III/IV non-haematological toxicity despite adequate medication (excluding grade III/IV nausea and vomiting), grade IV neutropenia lasting for more than five days or complicated by fever and/or platelets < 25 x 10^9/L, or grade IV oesophagitis or grade III oesophagitis lasting for more than two weeks.
Maximum tolerated dose (MTD) was defined as two or more patients in any cohort experiencing DLT.
|- Primary outcome||The aim of the study is to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC ias a onve every three weeks schedule.|
|- Secondary outcome||To determine the efficacy and progression-free and overall survival of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD, PHD MJA Jonge de |
|- CONTACT for SCIENTIFIC QUERIES||MD, PHD MJA Jonge de |
|- Sponsor/Initiator ||Erasmus Medical Center - Daniel den Hoed Kliniek, afdeling Interne Oncologie|
(Source(s) of Monetary or Material Support)
|Aventis Pharma, The Netherlands|
|- Publications||Lung Cancer. 2008 Jul;61(1):123-8. Epub 2008 Jan 7.|
|- Brief summary||Chemotherapy with concurrent thoracic radiotherapy (TRT) is considered standard treatment for limited-disease small cell lung cancer (LD-SCLC).|
The introduction of new chemotherapeutic agents and radiotherapy regimens may improve the prognosis of patients with LD-SCLC.
The camptothecin derivative irinotecan has shown good results in the treatment of patients with ED-SCLC.
Cisplatin and irinotecan have synergistic anti-tumor effects.
The present phase I trial was designed to determine the feasibility and tolerability of irinotecan and cisplatin in a 3-weekly schedule with concurrent once-daily TRT in LD-SCLC.
|- Main changes (audit trail)|
|- RECORD||20-mrt-2007 - 29-okt-2008|