ArticleAmerican journal of clinical oncology2009
Phase I trial of weekly topotecan and gemcitabine in patients with solid tumors.
Article in American journal of clinical oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 6 citations in OpenAlex.
- A novel oral camptothecin analog, gimatecan, exhibits superior antitumor efficacy than irinotecan toward esophageal squamous cell carcinoma in vitro and in vivo.Cell death & disease · 2018Article
- A phase I study of topotecan and gemcitabine in advanced solid tumors.Investigational new drugs · 2011Article
- Chemotherapy-induced weakness and fatigue in skeletal muscle: the role of oxidative stress.Antioxidants & redox signaling · 2011Review
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveThis phase I trial was designed to determine the maximal tolerated dose (MTD) of the combination of topotecan and gemcitabine given in a weekly schedule. MATERIALS AND
methodsIn this single-arm, open label, dose-escalation study, we administered topotecan (0.75-1.5 mg/m) and gemcitabine (1000 mg/m) on days 1, 8, and 15 every 4 weeks to 25 patients with advanced solid tumors.
resultsThe topotecan MTD, when combined with gemcitabine, was 1.25 mg/m/wk. Dose-limiting toxicities consisted of febrile granulocytopenia in 2 patients at the highest dose level. At the MTD, no episodes of granulocytopenia were observed, whereas 2/9 patients exhibited grade 3 thrombocytopenia. Other common grades 3-4 adverse events across all cohorts included non-neutropenic infections, fatigue, skin reactions, vomiting, and fever. One partial response and 2 stable diseases were observed in patients with nasopharyngeal carcinoma. Disease stabilization was also observed in patients with squamous cell carcinoma of the head and neck (3), nonsmall cell lung cancer (1), and thymoma (1).
conclusionsTopotecan and gemcitabine combined in a weekly schedule exhibit a favorable toxicity profile. Efficacy results support the further evaluation of this regimen in patients with head and neck cancer (particularly nasopharyngeal carcinoma).
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Registered trials
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