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
Secondary identifying numbers	N/A

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

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
Email	m.dejonge@erasmusmc.nl

Study information

Study design	Non-randomised, non-controlled, clinical trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Irinotecan and cisplatin
Primary outcome measure	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.
Secondary outcome measures	To determine the efficacy and progression-free and overall survival of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC.
Overall study start date	06/01/2003
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Daniel den Hoed Kliniek
Afdeling Interne Oncologie
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Funders

Funder type

Industry

Aventis Pharma (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.