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

Abstract

PURPOSE:

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.

PATIENTS AND 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.

• Authors: R P Wong, T Baetz, M J Krahn, J Biagi, N Wainman, E Eisenhauer, National Cancer Institute of Canada Clinical Trials Group
• Journal: Investigational new drugs (Invest New Drugs) Vol. 24 Issue 4 Pg. 347-51 (Jul 2006) ISSN: 0167-6997 [Print] United States
• PMID: 16502354 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• 2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide
• Carmustine

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Canada
• Carmustine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Colorectal Neoplasms (drug therapy, pathology, prevention & control)
• Dose-Response Relationship, Drug
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis (drug therapy)
• Neoplasm Recurrence, Local (drug therapy)
• Survival Rate