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A phase I clinical trial of irinotecan and carboplatin in patients with extensive stage small cell lung cancer

A phase I clinical trial of irinotecan and carboplatin in patients with extensive stage small cell lung cancer
A phase I clinical trial of irinotecan and carboplatin in patients with extensive stage small cell lung cancer
Background: Treatment options for small cell lung cancer (SCLC) remain inadequate. Irinotecan has been tested in various combinations with platinum agents but the optimal regimen remains uncertain. We undertook a phase I trial to optimise the dose intensity of a 3-weekly irinotecan/carboplatin combination. Methods: Twenty patients with extensive stage SCLC received intravenous carboplatin at an area under the curve (AUC) of 5 on day 1, and irinotecan in 40-70 mg/m(2) dose levels on days 1 and 8, every 21 days, for up to 6 cycles. Results: Dose-limiting toxicity occurred in 1 patient at the 50 mg/m(2) irinotecan level (grade 3 diarrhoea) and in 2 patients at 70 mg/m(2) (grade 5 neutropenic sepsis; combined grade 4 febrile neutropenia, grade 4 diarrhoea and grade 3 thrombosis). Toxicity patterns were consistent with the expected profile for this combination. The objective response rate was 75% and the median survival was 9.3 months (95% confidence interval 7.5-11.2). Conclusion: Irinotecan 60 mg/m(2) on days 1 and 8 combined with carboplatin AUC 5 every 21 days is recommended for phase II evaluation. This regimen has clinical activity, acceptable toxicity and greater dose intensity over those currently tested in phase III trials.
0009-3157
257-263
Crabb, Simon J.
bcd1b566-7677-4f81-8429-3ab0e85f8373
Bradbury, Jennifer
f6da29be-1cf1-44c4-9ec9-e95d1b115366
Nolan, Luke
76616eba-b3a6-4d74-ad1b-db49dd8ebc01
Selman, Diana
b5895ec4-47f3-4e53-a240-d4de9f362ccd
Muthuramalingam, Sethupathi R.
c988f19c-d942-4d7c-af2b-59c6d4642cff
Cave, Judith
60c67e39-121a-49ca-8594-93e8e456464f
Johnson, Peter W.M.
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Ottensmeier, Christian
42b8a398-baac-4843-a3d6-056225675797
Crabb, Simon J.
bcd1b566-7677-4f81-8429-3ab0e85f8373
Bradbury, Jennifer
f6da29be-1cf1-44c4-9ec9-e95d1b115366
Nolan, Luke
76616eba-b3a6-4d74-ad1b-db49dd8ebc01
Selman, Diana
b5895ec4-47f3-4e53-a240-d4de9f362ccd
Muthuramalingam, Sethupathi R.
c988f19c-d942-4d7c-af2b-59c6d4642cff
Cave, Judith
60c67e39-121a-49ca-8594-93e8e456464f
Johnson, Peter W.M.
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Ottensmeier, Christian
42b8a398-baac-4843-a3d6-056225675797

Crabb, Simon J., Bradbury, Jennifer, Nolan, Luke, Selman, Diana, Muthuramalingam, Sethupathi R., Cave, Judith, Johnson, Peter W.M. and Ottensmeier, Christian (2012) A phase I clinical trial of irinotecan and carboplatin in patients with extensive stage small cell lung cancer. Chemotherapy, 58 (4), 257-263. (doi:10.1159/000341274). (PMID:22907396)

Record type: Article

Abstract

Background: Treatment options for small cell lung cancer (SCLC) remain inadequate. Irinotecan has been tested in various combinations with platinum agents but the optimal regimen remains uncertain. We undertook a phase I trial to optimise the dose intensity of a 3-weekly irinotecan/carboplatin combination. Methods: Twenty patients with extensive stage SCLC received intravenous carboplatin at an area under the curve (AUC) of 5 on day 1, and irinotecan in 40-70 mg/m(2) dose levels on days 1 and 8, every 21 days, for up to 6 cycles. Results: Dose-limiting toxicity occurred in 1 patient at the 50 mg/m(2) irinotecan level (grade 3 diarrhoea) and in 2 patients at 70 mg/m(2) (grade 5 neutropenic sepsis; combined grade 4 febrile neutropenia, grade 4 diarrhoea and grade 3 thrombosis). Toxicity patterns were consistent with the expected profile for this combination. The objective response rate was 75% and the median survival was 9.3 months (95% confidence interval 7.5-11.2). Conclusion: Irinotecan 60 mg/m(2) on days 1 and 8 combined with carboplatin AUC 5 every 21 days is recommended for phase II evaluation. This regimen has clinical activity, acceptable toxicity and greater dose intensity over those currently tested in phase III trials.

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Published date: 15 August 2012
Organisations: Cancer Sciences

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Local EPrints ID: 342453
URI: https://eprints.soton.ac.uk/id/eprint/342453
ISSN: 0009-3157
PURE UUID: 6567c2c1-3998-4bed-bb26-a7c5fd4e074f
ORCID for Peter W.M. Johnson: ORCID iD orcid.org/0000-0003-2306-4974

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Date deposited: 30 Aug 2012 09:16
Last modified: 06 Jun 2018 12:57

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Contributors

Author: Simon J. Crabb
Author: Jennifer Bradbury
Author: Luke Nolan
Author: Diana Selman
Author: Sethupathi R. Muthuramalingam
Author: Judith Cave

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