A phase I study of GW572016 in patients with solid tumors

Minami, H.; Nakagawa, Katsuhiro; Kawada, Kenji; Mukai, H; Tahara, Makoto; Kurata, Teru; Uejima, Hisao; Nogami, Takashi; Sasaki, Yoh; Fukuoka, Miwa

doi:10.1200/jco.2004.22.14_suppl.3048

Cited by 15 publications

(6 citation statements)

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“…Numerous phase I combination trials have been conducted and are summarized in Table 1 [6, 30,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53].…”

Section: Phase I and Pharmacokinetic Clinical Trials With Lapatinibmentioning

confidence: 99%

Lapatinib: Current Status and Future Directions in Breast Cancer

2006

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Lapatinib is an oral receptor tyrosine kinase inhibitor, targeting both the ErbB-1 and ErbB-2 receptors. Preclinical in vitro and in vivo models indicate that lapatinib is active as monotherapy, synergistically in combination with trastuzumab, and in trastuzumab-resistant cell lines. Early clinical trials also provide evidence in patients that lapatinib is active against breast cancer. This paper reviews results of phase II and III clinical trials of lapatinib in metastatic breast cancer, evidence for its potential in patients with brain metastases, and current clinical trials as adjuvant treatment in earlystage disease. Our improved understanding of the biology of breast cancer and the use of biomarkers for identification of specific subtypes is allowing us to bring patient-specific novel therapies such as lapatinib to the clinic.

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“…Numerous phase I combination trials have been conducted and are summarized in Table 1 [6, 30,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53].…”

Section: Phase I and Pharmacokinetic Clinical Trials With Lapatinibmentioning

confidence: 99%

Lapatinib: Current Status and Future Directions in Breast Cancer

2006

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“…The EGF10003 18 study with a daily dosage range of 500-900 mg bid had a similar result as a grade 1-2 gastrointestinal events and rash. In Japan phase I study 19 was designed at doses of 900-1800 mg and the maximum tolerated dose was 1.800 mg daily, 2 patients had grade 2 diarrhea and 1 had grade 1 GGT elevation. These phase I studies recommended that the optimum dose of lapatinib was 1.500 mg daily.…”

Section: Discussionmentioning

confidence: 99%

Does Lapatinib Increase Pulmonary Toxicity when Concurrently Used with Radiation Therapy? An Experimental Study with Wistar-Albino Rats

Doğan¹

2018

UHOD

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Lapatinib is an oral receptor tyrosine kinase inhibitor which has shown activity in the treatment of metastatic breast cancer. There is no data regarding the side effects of combination of radiotherapy and Lapatinib. 40 female Wistar-albino rats (WAR) were divided into 4 groups; G1 did not receive any treatment, G2 received radiotherapy to whole thoracic region, G3 received Lapatinib without radiotherapy, G4 received Lapatinib with radiotherapy. A total dose of 30 Gy in 10 fractions was given to both lungs. Lapatinib equivalent to 1500 mg/day were calculated according to the mean weight of rats, orally administrated. A comparative analysis was performed by scoring the pulmonary injury between 0 and 3 according to the infiltration of inflammatory cells into the alveolar spaces, alveolar wall thickening and architectural deformation across the entire lung section. In G2 inflammatory cell infiltration, fibrosis with damage to lung structure andformation of small fibrous masses were observed. Alveolar septa were significantly thicker than G1 (p≤ 0.001), which revealed totally normal pulmonary structure. G3 showed minimal alveolar septal thickening and infiltration of inflammatory cells into the alveolar spaces which was not significantly different than G1. Histopathological findings in G4 were similar to those in G2 and statistically different when compared with the G1 and G3 (p≤ 0.001). In this experimental study it has been shown that addition of Lapatinib to radiation did not increase RIPF in rats.

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“…Various phase I trials of lapatinib have been conducted in patients with solid tumors including cervical cancer and ovarian cancer (52,53) . These studies report acneiform rash, diarrhea, anorexia, fatigue, stomatitis, nausea, and vomiting as the most common adverse effects.…”

Section: Lapatinib/gw572016mentioning

confidence: 99%

“…Lapatinib has demonstrated superior in vitro antitumor activity in combination with taxanes, when compared to either agent alone (54) . Phase I trials have shown that lapatinib is well tolerated orally in doses from 900 to 1600 mg/day once daily, with preliminary evidence of antitumor activity in heavily pretreated patients (52) . Serum vascular endothelial growth factor (VEGF) may be a potential biomarker for lapatinib activity (53) .…”

Section: Lapatinib/gw572016mentioning

confidence: 99%

The emerging role of epidermal growth factor receptor inhibitors in ovarian cancer

Palayekar

Herzog

2008

Int J Gynecol Cancer

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Epidermal growth factor receptor (EGFR) inhibitors are a new biologically targeted therapy, which may offer new hope in the treatment of patients with advanced or recurrent ovarian cancers. In this review, we summarize and discuss the results of research to date on EGFR inhibitors with particular emphasis on ovarian cancer. We reviewed data identified by searches of MEDLINE, PubMed, and abstracts from the proceedings of the American Society of Clinical Oncology meetings from 1998 to 2006, with the search terms "Ovarian Cancer,""EGFR,""gefitinib, ZD1839, Iressa,""erlotinib, OSI-774, Tarceva,""CI-1033,"" GW 572016, lapatinib,""PKI-166,""EKB 569,""anti-EGFR antibodies,""trastuzumab, Herceptin,""cetuximab, Erbitux, IMC-C225,""matuzumab, EMD 72000,""panitumamab, ABX-EGF,""pertuzumab," and "vandetanib, rINN, Zactima, ZD6474." Phase II trials of both small molecule inhibitors of EGFR- and antibody-based inhibitors are currently ongoing in ovarian cancer and emerging data suggest that their activity in unselected women with advanced or recurrent ovarian cancer is modest, when utilized as a single agent. It is possible that these agents will be highly effective in smaller subsets of patients whose tumors are dependent on EGFR signaling, perhaps through activating mutations in EGFR or its downstream pathway. Targeted therapy with EGFR inhibitors is an untapped potential resource in the treatment of advanced or recurrent ovarian cancer. Ongoing trials will elucidate the most effective strategies to use these agents individually or in combination with traditional chemotherapeutic agents.

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A phase I study of GW572016 in patients with solid tumors

Cited by 15 publications

References 0 publications

Lapatinib: Current Status and Future Directions in Breast Cancer

Lapatinib: Current Status and Future Directions in Breast Cancer

Does Lapatinib Increase Pulmonary Toxicity when Concurrently Used with Radiation Therapy? An Experimental Study with Wistar-Albino Rats

The emerging role of epidermal growth factor receptor inhibitors in ovarian cancer

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