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.
ID
Bron
Verkorte titel
Aandoening
Limited-disease small cell lung cancer (LD-SCLC).
Ondersteuning
Erasmus University Medical Center / Daniel den Hoed Kliniek
3008 AE ROTTERDAM
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Medical Oncology
P.O. Box 5201
MJA Jonge de
Rotterdam 3008 AE
The Netherlands
+31 10 4391 760
m.dejonge@erasmusmc.nl
Wetenschappelijk
Department of Medical Oncology
P.O. Box 5201
MJA Jonge de
Rotterdam 3008 AE
The Netherlands
+31 10 4391 760
m.dejonge@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL913 |
| NTR-old | NTR937 |
| Ander register | : |
| ISRCTN | ISRCTN75771514 |