Phase I study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer
| ISRCTN | ISRCTN75771514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75771514 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Aventis Pharma (The Netherlands) |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 05/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M J A de Jonge
Scientific
Scientific
Erasmus University Medical Centre/Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 439 1760 |
|---|---|
| m.dejonge@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled, clinical trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Phase I study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer |
| Study objectives | 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 Limited-Disease Small Call Lung Cancer (LD-SCLC) at a once every three weeks schedule. |
| Ethics approval(s) | Ethics approval received from the Ethical board of the Erasmus MC on the 18th April 2003 (ref: MEC 216.449/2002/180). |
| Health condition(s) or problem(s) studied | Limited-Disease Small Cell Lung Cancer (LD-SCLC) |
| Intervention | Patients were treated at day one of three-weekly cycles one and four 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 one of cycles two and three with concurrent thoracic radiotherapy (total dose 45 Gy) was performed. At each dose level three patients were included. Dose-Limiting Toxicity (DLT) was defined as one patient in any cohort having any of the following toxicities during cycle two and three (with concurrent thoracic radiotherapy): 1. Grade III/IV non-haematological toxicity despite adequate medication (excluding grade III/IV nausea and vomiting) 2. Grade IV neutropenia lasting for more than five days or complicated by fever and/or platelets less than 25 x 10^9/L, or 3. 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. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Irinotecan and cisplatin |
| Primary outcome measure(s) |
The aim of the study is to determine the DLT and MTD of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC in a once every three weeks schedule. |
| Key secondary outcome measure(s) |
To determine the efficacy and progression-free and overall survival of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC. |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 9 |
| Key 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 zero or one 6. Adequate organ functions: a. White Blood Cells (WBC) greater than 3.0 x 10^9/L b. Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L c. platelets greater than 100 x 10^9/L d. serum creatinine less than 135 mmol/L or creatinine clearance according to Cockroft-Gault formula greater than 60 ml/min e. bilirubin less than 1.25 Upper Limit of Normal (ULN) f. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) less than 2.5 ULN g. Lactate Dehydrogenase (LDH) less than 1.25 ULN 7. Adequate pulmonary function (Forced Expiratory Volume in one second [FEV1] greater than 30% of predicted, Diffusing capacity of the Lung for Carbon Monoxide [DLCO] greater than 40% of predicted) 8. No prior malignancy unless five 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 |
| Key exclusion criteria | 1. Other serious illnesses 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 |
| Date of first enrolment | 06/01/2003 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University Medical Centre/Daniel den Hoed Kliniek
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2008 | 04/01/2021 | Yes | No |
Editorial Notes
04/01/2021: Publication reference added.
