SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group

To evaluate the activity and toxicity of SarCNU, an oral chloroethylnitrosourea in patients with recurrent or metastatic colorectal cancer who have progressed after first-line chemotherapy. Eighteen patients with recurrent or metastatic colorectal cancer following first-line chemotherapy were treate...

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Bibliographic Details
Published in:Investigational new drugs 2006-07, Vol.24 (4), p.347-351
Main Authors: Wong, R P, Baetz, T, Krahn, M J, Biagi, J, Wainman, N, Eisenhauer, E
Format: Article
Language:English
Subjects:
Adult
Aged
Angina pectoris
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Brain cancer
Canada
Cancer therapies
Carmustine - administration & dosage
Carmustine - adverse effects
Carmustine - analogs & derivatives
Carmustine - therapeutic use
Chemotherapy
Clinical trials
Colorectal cancer
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Colorectal Neoplasms - prevention & control
Creatinine
Dose-Response Relationship, Drug
Drug dosages
Female
Humans
Male
Medical imaging
Metastasis
Middle Aged
Neoplasm Metastasis - drug therapy
Neoplasm Recurrence, Local - drug therapy
Neutropenia
Patients
Response rates
Skin cancer
Steroids
Survival Rate
Thrombocytopenia
Toxicity
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Summary:To evaluate the activity and toxicity of SarCNU, an oral chloroethylnitrosourea in patients with recurrent or metastatic colorectal cancer who have progressed after first-line chemotherapy. Eighteen patients with recurrent or metastatic colorectal cancer following first-line chemotherapy were treated with SarCNU 860 mg/m2 orally day 1, 5 and 9 every 6 weeks. The patient's median age was 64 and the ECOG performance status was 0 in six, 1 in eleven and 2 in one patients. All patients were evaluable for toxicity and 16 were evaluable for response. There were no objective responses (0%). One patient had stable disease and 15 had progressive disease at their first follow-up assessment. Median survival was 7.36 months (3.75-7.49 95% C.I.). Neutropenia and thrombocytopenia were the most severe toxicities (grade 3-4 in six and nine patients respectively). Pulmonary toxicity was also seen in five patients who had a drop of DLCO grade from baseline and two patients who had a fall in FVC from baseline. SarCNU is inactive in recurrent or metastatic colorectal patients who have progressed after first-line chemotherapy.
ISSN:0167-6997
1573-0646
DOI:10.1007/s10637-006-5730-2