Abstract | PURPOSE: PATIENTS AND METHODS: This was a non-randomised, multi-centre, two-step Fleming design phase II study. Eligible patients with locally advanced (inoperable) or metastatic gastric or gastro-oesophageal adenocarcinoma, with measurable disease, ECOG performance status < or =2, with adequate haematological, renal and hepatic function, who had received < or =1 prior chemotherapy regimen for advanced disease, were treated with 7,000 mg/m(2) of pegamotecan as a 1-h infusion every 21 days until disease progression or unacceptable toxicity. The primary efficacy measure was the objective response rate. RESULTS: Five of the 35 patients recruited into this study had a partial response (14.3%), with a median time to progression of 11.9 weeks (95% CI: 6.6, 13.1), and median overall survival of 38.1 weeks (95% CI: 29.0, 47.3). Grade 3/4 toxicities included neutropenia in 6 (17.1%) patients, thrombocytopenia in 4 (11.4%), fatigue in 8 (22.9%), nausea in 6 (17%), vomiting in 6 (17%) and anorexia in 4 (11.4%) patients. There were no episodes of febrile neutropenia and no toxic deaths. CONCLUSIONS:
Pegamotecan has activity in this patient population and was generally well-tolerated. The favourable rate of haematological toxicities and diarrhoea compared with irinotecan in similar studies suggests that pegamotecan could be combined with other active agents in further studies in this disease.
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Authors | L C Scott, J C Yao, A B Benson 3rd, A L Thomas, S Falk, R R Mena, J Picus, J Wright, M F Mulcahy, J A Ajani, T R J Evans |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 63
Issue 2
Pg. 363-70
(Jan 2009)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 18398613
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Polyethylene Glycols
- pegamotecan
- Camptothecin
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Topics |
- Adenocarcinoma
(drug therapy, pathology)
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Drug Administration Schedule
- Esophagogastric Junction
(pathology)
- Female
- Humans
- Infusions, Intravenous
- Male
- Middle Aged
- Neoplasm Invasiveness
- Neoplasm Metastasis
- Neoplasm Staging
- Polyethylene Glycols
(administration & dosage, adverse effects, therapeutic use)
- Quality of Life
- Stomach Neoplasms
(drug therapy, pathology)
- Treatment Outcome
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