A phase I trial of gemcitabine and topotecan in previously treated ovarian or peritoneal cancer: A Gynecologic Oncology Group study

Chen, M. Dwight; Fleming, Gini F.; Mitchell, S.K.; Horowitz, Ira

doi:10.1016/j.ygyno.2005.07.114

Cited by 3 publications

(2 citation statements)

References 21 publications

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“…14–16 This high incidence of bone marrow supression associated with this combination is further illustrated by a more recent gynecologic oncolology group study, which failed to find a safe regimen of gemcitabine combined with consecutive-day dosing schedule of topotecan in women with previously treated ovarian and peritoneal cancers. 17 …”

Section: Discussionmentioning

confidence: 99%

Phase I Trial of Weekly Topotecan and Gemcitabine in Patients With Solid Tumors

William

Lee

Shin

et al. 2009

American Journal of Clinical Oncology

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Objective This 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 Methods In this single-arm, open label, dose-escalation study, we administered topotecan (0.75–1.5 mg/m2) and gemcitabine (1000 mg/m2) on days 1, 8, and 15 every 4 weeks to 25 patients with advanced solid tumors. Results The topotecan MTD, when combined with gemcitabine, was 1.25 mg/m2/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). Conclusions Topotecan 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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Section: Discussionmentioning

confidence: 99%

Phase I Trial of Weekly Topotecan and Gemcitabine in Patients With Solid Tumors

William

Lee

Shin

et al. 2009

American Journal of Clinical Oncology

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“…Trials using combination gemcitabine and topotecan for patients with recurrent ovarian cancer used different regimens and had variable results [53][54][55]. The GOG Phase I trial by Chen and colleagues was closed early owing to the high rates of neutropenia, thrombocytopenia and stomatitis (Table 7) [55].…”

Section: Other Combination Chemotherapy Regimens That Contain Gemcitamentioning

confidence: 99%

Role of Gemcitabine in the Treatment of Ovarian Cancer

Abushahin

Rose²

2007

Womens Health (Lond Engl)

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The US FDA has recently approved the combination of carboplatin and gemcitabine as a second-line therapy for recurrent platinum-sensitive ovarian cancer. This article briefly reviews the pharmacokinetics and mechanism of action of gemcitabine and its synergistic effect with platinum. An overview of the literature on the role of gemcitabine in the treatment of epithelial ovarian cancer is also presented.

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