Condition category
Cancer
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
02/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M J A de Jonge

ORCID ID

Contact details

Erasmus University Medical Centre/Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1760
m.dejonge@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study 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 Limited-Disease Small Call Lung Cancer (LD-SCLC) at a once every three weeks schedule.

Ethics approval

Ethics approval received from the Ethical board of the Erasmus MC on the 18th April 2003 (ref: MEC 216.449/2002/180).

Study design

Non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Irinotecan and cisplatin

Primary outcome measures

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 trial start date

06/01/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

9

Participant 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

Recruitment start date

06/01/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre/Daniel den Hoed Kliniek
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Industry

Funder name

Aventis Pharma (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes