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Phase II trial of 9-aminocamptothecin
Phase II trial of 9-aminocamptothecin
* w w w .ingentaconnect . com /content/klu/drug/1998/00000016/00000004/00207259
Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a
120-hour continuous infusion weekly for three weeks in metastatic
colorectal carcinoma
Authors: Pazdur R.1; Medgyesy D.C.1; Winn R.J.1; Dakhil S.R.2; Moore Jr.
D.F.2; Scalzo A.3; Hoff P.M.1; Arbuck S.G.4; Abbruzzese J.L.1
Source: Investigational New Drugs, Volume 16, Number 4, 1998 , pp.
341-346(6)
Abstract:
9-Aminocamptothecin (9-AC) is a camptothecin derivative with broad
antitumor activity in preclinical studies. Prior investigations suggested
that prolonged maintenance of 9-AC lactone plasma concentrations above 10
nmol/l and frequent administration of the drug are important determinants
of antitumor activity. Our phase II study, therefore, examined a 5-day
continuous infusion of 9-AC weekly for 3 weeks in patients with advanced
colorectal cancer. Eighteen patients previously untreated for metastatic
disease received 480 mgrg/m^2/day of 9-AC. No responses were observed in
17 evaluable patients. Severe toxicities included granulocytopenia,
nausea, vomiting and diarrhea. The median absolute granulocyte count (AGC)
nadir was 2,300/mgrl (range 0–9,000/mgrl) and occurred on day 10. Eight
patients received an escalated dose of 600 mgrg/m^2/day. The median AGC
nadir at the escalated dose was 1,500/mgrl (range: 300–2,700/mgrl) and
occurred on day 22. The median number of courses given was 2 (range: 1–8);
and the median time to disease progression was 8 weeks (range: 1–40
weeks). 9-AC administered by this schedule lacked antitumor activity in
patients with advanced colorectal carcinomas.
Keywords: 9-AC; 9-aminocamptothecin; camptothecin; colorectal cancer;
phase II
Affiliations: 1: Division of Medicine, University of Texas M.D. Anderson
Cancer Center, Houston, TX 2: Wichita CCOP, Wichita, KS 3: Syracuse
CCOP, Syracuse, NY 4: Division of Cancer Treatment and Diagnosis,
National Cancer Institute, Bethesda, MD, USA
* w w w .ingentaconnect . com /content/klu/drug/1998/00000016/00000004/00207259
Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a
120-hour continuous infusion weekly for three weeks in metastatic
colorectal carcinoma
Authors: Pazdur R.1; Medgyesy D.C.1; Winn R.J.1; Dakhil S.R.2; Moore Jr.
D.F.2; Scalzo A.3; Hoff P.M.1; Arbuck S.G.4; Abbruzzese J.L.1
Source: Investigational New Drugs, Volume 16, Number 4, 1998 , pp.
341-346(6)
Abstract:
9-Aminocamptothecin (9-AC) is a camptothecin derivative with broad
antitumor activity in preclinical studies. Prior investigations suggested
that prolonged maintenance of 9-AC lactone plasma concentrations above 10
nmol/l and frequent administration of the drug are important determinants
of antitumor activity. Our phase II study, therefore, examined a 5-day
continuous infusion of 9-AC weekly for 3 weeks in patients with advanced
colorectal cancer. Eighteen patients previously untreated for metastatic
disease received 480 mgrg/m^2/day of 9-AC. No responses were observed in
17 evaluable patients. Severe toxicities included granulocytopenia,
nausea, vomiting and diarrhea. The median absolute granulocyte count (AGC)
nadir was 2,300/mgrl (range 0–9,000/mgrl) and occurred on day 10. Eight
patients received an escalated dose of 600 mgrg/m^2/day. The median AGC
nadir at the escalated dose was 1,500/mgrl (range: 300–2,700/mgrl) and
occurred on day 22. The median number of courses given was 2 (range: 1–8);
and the median time to disease progression was 8 weeks (range: 1–40
weeks). 9-AC administered by this schedule lacked antitumor activity in
patients with advanced colorectal carcinomas.
Keywords: 9-AC; 9-aminocamptothecin; camptothecin; colorectal cancer;
phase II
Affiliations: 1: Division of Medicine, University of Texas M.D. Anderson
Cancer Center, Houston, TX 2: Wichita CCOP, Wichita, KS 3: Syracuse
CCOP, Syracuse, NY 4: Division of Cancer Treatment and Diagnosis,
National Cancer Institute, Bethesda, MD, USA
