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


METHODS
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.


RESULTS
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.


CONCLUSIONS
SarCNU is inactive in recurrent or metastatic colorectal patients who have progressed after first-line chemotherapy.
Wong
R P
RP
Cancer Care Manitoba, St. Boniface General Hospital, 409, Winnipeg, Manitoba, Canada. ralph.wong@cancercare.mb.ca
Baetz
T
T
Krahn
M J
MJ
Biagi
J
J
Wainman
N
N
Eisenhauer
E
E
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D015996:Survival Rate
D000970:Antineoplastic Agents; C044565:2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide; D002330:Carmustine