scholarly journals Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two Phase II trials

2015 ◽  
pp. 83
Author(s):  
Carrie Smith ◽  
Ronald Yanagihara ◽  
Marek Spaczyński ◽  
William Cooper ◽  
Erin O’Boyle ◽  
...  
Keyword(s):  
Phase Ii ◽  
Extended Release ◽  
Emetogenic Chemotherapy ◽  
Phase Ii Trials ◽  
Highly Emetogenic Chemotherapy ◽  
Two Phase ◽  
Safety And Efficacy

Responses to second-line cisplatin-based intraperitoneal therapy in ovarian cancer: influence of a prior response to intravenous cisplatin.

1991 ◽  
Vol 9 (10) ◽  
pp. 1801-1805 ◽  
Author(s):  
M Markman ◽  
B Reichman ◽  
T Hakes ◽  
W Jones ◽  
J L Lewis ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Small Volume ◽  
Recurrent Ovarian Cancer ◽  
Second Line ◽  
Front Line ◽  
Phase Ii Trials ◽  
Two Phase ◽  
Overall Response ◽  
Intraperitoneal Therapy

Phase II trials of second-line intraperitoneal (IP) cisplatin-based therapy in patients with ovarian cancer have demonstrated the ability of this approach to produce objective antitumor responses, including surgically defined complete responses (CRs), in individuals with persistent small-volume disease after front-line cisplatin-based intravenous (IV) treatment. To examine the influence of a prior response to systemic cisplatin on the activity of second-line IP cisplatin, we retrospectively analyzed two phase II trials of cisplatin-based IP therapy in persistent/recurrent ovarian cancer conducted at our institution. Of the 89 assessable patients on the two trials, 52 (58%) had previously responded to IV cisplatin. The overall response and CR rates to second-line IP cisplatin-based therapy in this previously responding population were 56% and 33%, respectively, compared with overall response and CR rates in the 37 nonresponders to IV cisplatin of 11% and 3%, respectively (P less than .001; chi 2, 1 df). In the 36 patients responding to systemic cisplatin and whose largest tumor mass measured less than 1 cm at IP cisplatin initiation, a 42% CR rate was observed, compared with a 7% CR rate in the 14 patients with the same bulk of disease who had previously failed to respond to systemic cisplatin (P less than .025). We conclude that a prior response to systemic cisplatin strongly influences the antineoplastic activity of second-line IP cisplatin in ovarian cancer.

Combined analysis of two phase II trials of imatinib in advanced dermatofibrosarcoma protuberans (DFSP)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10520-10520 ◽  
Author(s):  
S. Schuetze ◽  
P. Rutkowski ◽  
M. M. Van Glabbeke ◽  
C. Rankin ◽  
B. P. Rubin ◽  
...  
Keyword(s):  
Phase Ii ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Locally Advanced ◽  
Chromosome 17 ◽  
Low Grade ◽  
Time To Progression ◽  
Phase Ii Trials ◽  
Two Phase

10520 Background: DFSP is an infiltrative, low-grade, dermal tumor with propensity to recur locally and occasionally metastasize. Translocation between COL1A1 on chromosome 17 and PDGFB on chromosome 22, which results in transcriptional upregulation of PDGFB, is characteristic of DFSP. Autocrine/paracrine PDGFB-mediated activation of PDGFRB drives DFSP proliferation. Two distinct phase II trials of imatinib in patients (pts) with locally advanced or metastatic DFSP were conducted, 1 in North America (SWOG) with confirmed objective response rate and 1 in Europe (EORTC) with 14 week progression-free rate as primary end-points. Methods: Pts with locally advanced or metastatic DFSP were eligible. In the EORTC trial confirmation of t(17;22) by FISH was prospectively required for participation, imatinib was started at 400mg bid, surgery was undertaken after 14 weeks if feasible and response was assessed at 14 weeks. Full accrual was to be 44 pts in one step. In the SWOG trial confirmation of t(17;22) by RT-PCR was performed after enrollment, imatinib was started at 400mg daily and response was assessed every 8 weeks. Full accrual was to be 40 pts in 2 steps. Results: 16 pts were enrolled in EORTC and 8 pts enrolled in SWOG trial. The studies were closed early because of slow accrual and regulatory approval of imatinib in DFSP. Pts age ranged from 24 to 70 yrs, DFSP was located on head/neck, trunk and extremity in 7, 11 and 6 pts, respectively, ranged in size from 1.2–49 cm and was classic, pigmented and fibrosarcomatous DFSP in 13, 1 and 7 pts, respectively. One patient did not have DFSP on central review, lacked t(17;22) and thus was ineligible. Metastases were present in 7 pts involving lung in 6 pts. 11 pts (46%) had partial response, 9 pts had stable disease and 4 pts had progressive disease as best response. Median time to progression was 1.7 yrs. Response and progression-free at 1 yr rates were similar between studies. Imatinib was stopped in 11 pts for progression, 1 pt for toxicity, 2 pts resected free of gross disease and 1 pt withdrew. Conclusions: Imatinib is active in DFSP harboring t(17;22) with an objective response rate approaching 50% and is active in fibrosarcomatous DFSP. Response rates and time to progression did not appear to differ between pts taking 400 mg daily versus 400 mg bid. [Table: see text]

Safety and efficacy of first-line XELIRI with or without bevacizumab in patients with metastatic colorectal cancer: Analysis of two phase II studies.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 560-560
Author(s):  
P. Garcia-Alfonso ◽  
S. Alvarez ◽  
A. Munoz ◽  
P. Lopez ◽  
C. Riesco ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Safety Data ◽  
Patient Characteristics ◽  
First Line ◽  
Two Phase ◽  
Safety And Efficacy ◽  
Phase Ii Studies

560 Background: The safety and efficacy of first-line XELIRI (capecitabine in combination with irinotecan) and XELIRI plus bevacizumab (BEV) have been evaluated in patients with metastatic colorectal cancer (mCRC). To date, however, no randomized studies comparing these regimens have been performed. This retrospective analysis compared efficacy and safety data for the two regimens from separate phase II studies performed at a single institution. Methods: Patients with histologically documented metastatic or recurrent CRC and no prior treatment for advanced disease received irinotecan 175 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily on days 2-8 every 2 weeks (XELIRI study). For patients age ≥65 years, the starting doses of irinotecan and capecitabine were reduced to 140 mg/m2 and 750 mg/m2, respectively. In the second study, patients received the same regimen plus BEV 5 mg/kg on day 1 (XELIRI + BEV study). Results: A total of 53 and 46 patients were entered into the XELIRI and XELIRI + BEV studies, respectively. Patient characteristics were generally similar in both groups. Efficacy results for the ITT populations are summarized in the Table. Patients treated with XELIRI + BEV had a significantly higher ORR and longer median TTP vs. XELIRI alone and a numerically longer median OS was observed (p=NS). The overall incidence of adverse events (all grades or grade 3/4) was similar in the two groups, although alopecia, mucositis, hand–foot syndrome, and haemorrhage were more common with XELIRI + BEV vs. XELIRI alone (all p<0.05). Conclusions: In this retrospective comparison of two studies, the addition of BEV to XELIRI appeared to improve outcome relative to XELIRI alone in the first-line treatment of patients with mCRC. The overall incidence of adverse events was similar in the two groups. [Table: see text] No significant financial relationships to disclose.

A double-blind randomized phase II study of 10 versus 5 mg olanzapine for emesis induced by highly emetogenic chemotherapy with cisplatin.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 10111-10111 ◽  
Author(s):  
Hironobu Hashimoto ◽  
Takako Yanai ◽  
Kengo Nagashima ◽  
Natsuko Okita Tsuda ◽  
Hidehito Horinouchi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Randomized Phase Ii

Impact of gender on multikinase inhibitors (MKIs) toxicity in patients (pts) with advanced pancreatic and gastrointestinal neuroendocrine tumors (NETs): A pooled analysis of two phase II trials with pazopanib and lenvatinib.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4109-4109
Author(s):  
Jorge Hernando-Cubero ◽  
Enrique Grande ◽  
Daniel E. Castellano ◽  
Toni Ibrahim ◽  
Nicola Fazio ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Phase Ii ◽  
Liver Toxicity ◽  
Task Force ◽  
Pooled Analysis ◽  
Phase Ii Trials ◽  
Open Label ◽  
Two Phase ◽  
Phase Ii Studies ◽  
Grade 3

4109 Background: Retrospective data in some cancer types suggested a possible different toxicity profile with chemotherapy and targeted therapies according to gender. However, data from prospective studies are still very limited, especially in infrequent tumors such as NETs. Methods: Pts with advanced pancreatic and gastrointestinal NETs treated with pazopanib or lenvatinib in the multicenter open-label phase II studies PAZONET and TALENT respectively, were included in the analysis. Both studies were performed by Spanish Task Force Group for Neuroendocrine Tumors (GETNE). All toxicity grades with an incidence higher than 5% were considered for univariate review. Additionally, all grade 3-4 toxicities were analyzed separately. Results: 155 pts (47.7% female) with 1213 adverse events (AEs) (20% G3-4) divided in 121 categories were included. In female patients, liver toxicity, headache, pyrexia, nausea/vomiting, hair/skin disorders and dizziness were significantly more common (table). The only toxicity with higher incidence in men was dysphonia (OR 0.42, 95% CI 0.2-0.9, p 0.02). There were no gender differences in grade 3-4 toxicities. Conclusions: We observed significant differences in toxicity AEs by gender in two prospective phase II studies with MKIs in NETs patients. Potential different approach to manage toxicity may be adopted based on gender. [Table: see text]

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