Steroid-free regimen with aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX chemotherapy: A randomized phase III trial.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS820-TPS820
Author(s):  
Wenjing Wang ◽  
Jiayu Ling ◽  
Yue Cai ◽  
Jianwei Zhang ◽  
Huabin Hu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Receptor Antagonist ◽  
Rescue Medication ◽  
Performance Status ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Trial ◽  
Delayed Nausea ◽  
To Receive

TPS820 Background: Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX (oxaliplatin, leucovorin and 5-fluorouracil) chemotherapy. Methods: This trial is an open-label, single-center, randomized phase 2 study. Eligibility criteria include histologically confirmed colorectal cancer, no prior chemotherapy and scheduled to receive FOLFOX, Age ≥ 18 years, ECOG Performance Status 0, 1 or 2. Up to 298 patient will be enrolled and randomized 1:1 to receive aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus tropisetron (5mg IV of day1) or dexamethasone (10 mg IV on day 1 and 5 mg IV on days 2, 3) plus Tropisetron (5mg IV of day1). The primary objective of this study is complete response defined as no emetic episodes and no use of rescue medication. The second objectives include nausea score, time to first vomiting episode or use of rescue medication, frequency of rescue medication and functional Living Index -Emesis (FLIE). Clinical trial information: NCT02909478.

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)

2017 ◽  
Vol 35 (31) ◽  
pp. 3558-3565 ◽  
Author(s):  
Lingyun Zhang ◽  
Xiujuan Qu ◽  
Yuee Teng ◽  
Jing Shi ◽  
Ping Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Delayed Nausea

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

Sustainability of antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of moderately (MEC) and highly (HEC) emetogenic chemotherapy regimens: Results of a randomized phase III trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9626-9626
Author(s):  
Ralph V. Boccia ◽  
William Cooper ◽  
Erin O'Boyle
Keyword(s):  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Phase Iii ◽  
Sustained Delivery ◽  
Test Results ◽  
Phase Iii Trial ◽  
Multiple Cycles ◽  
To Receive ◽  
Delayed Phase ◽  
Clinical Trial Information

9626 Background: Patients receiving MEC or HEC were administered subcutaneous (SC) APF530 500 mg, a sustained delivery formulation of granisetron (10 mg). The complete antiemetic response rates (CR; no emetic episodes and no rescue medication) were non-inferior to those of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) (Grous et al. ASCO 2009, #9627). We report on sustainability of CR with APF530 (10 mg) during multiple chemotherapy cycles in this study. Methods: 1428 patients scheduled to receive single doses of MEC or HEC were randomized to APF530 SC (5 or 10 mg granisetron) or 0.25 mg palonosetron intravenously (IV) prior to cycle 1 (C1). In C2-4, patients who received palonosetron in C1 were randomized to APF530 5 or 10 mg; those who received APF530 continued with their C1 APF530 dose. Treatment cycles were separated by 7-28 days. CR rates were compared between cycles using McNemar’s test. Results: No significant differences in within-cycle CR occurred between APF530 doses during acute and delayed phases in C2-4 for MEC and HEC, but a trend toward higher CR rates was seen in successive cycles. For the 2 doses, CR was sustained across all 4 cycles in 56.5-62.6% and 68.4-71.7% in acute phase, and 41.8-42.4% and 57.5-57.9% in delayed phase with MEC and HEC, respectively. Examination of CR rates in C2, C3, or C4 compared with the rate in C1 showed that CR rates were sustained and that the proportion of patients with no CR in C1 but CR in later cycles was consistently higher than that of patients with CR in C1 but no CR later. For illustration, the table shows C4 CR and C1 CR for patients who received APF530 10 mg in C1 and C4. Conclusions: CR rates achieved with APF530 during acute and delayed phases of CINV in MEC and HEC were maintained over multiple cycles. Clinical trial information: NCT00343460. [Table: see text]

Prospective observational study on chemotherapy-induced nausea and vomiting (CINV) for colorectal cancer patients by the CINV study group of Japan.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 652-652
Author(s):  
Yuji Miyamoto ◽  
Hideo Baba ◽  
Yasushi Tsuji ◽  
Ayako Doi ◽  
Koji Takeda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Observational Study ◽  
Receptor Antagonist ◽  
Motion Sickness ◽  
Prospective Observational Study ◽  
Incidence Rates ◽  
Nausea And Vomiting ◽  
Acute Nausea ◽  
Delayed Nausea ◽  
Acute Cinv

652 Background: The aim of this study is to investigate the incidence of Chemotherapy Induced Nausea and Vomiting (CINV) among moderately emetogenic chemotherapy-naive patients with colorectal cancer. We also assessed whether the medical staff accurately recognized the incidence of CINV in their own practices. Methods: A prospective observational study of patients receiving the first cycle of oxaliplatin or irinotecan-based chemotherapy was performed. A 7-day diary for CINV was provided to the patients prior to chemotherapy to record daily incidence of CINV. Observed incidence rates of acute (day1) and delayed (days 2-7) CINV were compared with medical staff's predictions. Results: A total of 191 patients (110 males and 81 females) were registered during the period from April 2011 to December 2012. All patients were treated with oxaliplatin-based (n = 175) or irinotecan-based chemotherapy (n = 16). Acute vomiting was observed in 4 patients (2.1%), while delayed vomiting was observed in 19 patients (10.0%). Acute nausea occurred in 14 patients (7.3%), while 63 patients (33%) were affected by delayed nausea. Irinotecan significantly induced acute nausea more frequently than oxaliplatin did (p = 0.019). The presence of motion sickness was significantly associated with the incidence of acute nausea (p < 0.001) and vomiting (p = 0.003). Antiemetics were given along the guideline to all patients. 58 patients were administered a neurokinin-1 (NK1) receptor antagonist. Patients with NK-1 receptor antagonist showed significantly less incidence of delayed vomiting than patients without one (3% vs 13%, p = 0.048). 30 patients (15.7%) required rescue antiemetics. The staff had estimated the incidence of acute CINV in 91 patients (47.6%). However, only 14 patients (7.3%) really experienced acute CINV. Conclusions: CINV seems to be controllable with appropriate management, but delayed CINV still remains an important problem to be targeted. The presence of motion sickness should be affected by efficient antiemetic management. The extent of CINV in this patient group seems to be overestimated.

EORTC 1709/CCTG CE.8: A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS2072-TPS2072 ◽  
Author(s):  
Patrick Roth ◽  
Jaap C. Reijneveld ◽  
Thierry Gorlia ◽  
Frederic Dhermain ◽  
Filip Yves Francine Leon De Vos ◽  
...  
Keyword(s):  
Standard Treatment ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Primary Objective ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Open Label ◽  
Phase Iii Trial ◽  
Newly Diagnosed Glioblastoma

TPS2072 Background: The standard treatment for patients with newly diagnosed glioblastoma comprises maximum safe surgery, radiotherapy (RT), and concomitant and up to six cycles of maintenance temozolomide (TMZ) chemotherapy (TMZ/RT→TMZ). Despite this intense therapy, the prognosis remains poor and there is an urgent need to develop new therapeutic options. Marizomib is a novel, irreversible and brain-penetrant pan-proteasome inhibitor. Following its successful assessment in phase I trials in patients with newly diagnosed as well as recurrent glioblastoma, marizomib is now being investigated in a phase III trial. Methods: EORTC 1709/CCTG CE.8 is a multicenter, randomized, controlled, open label phase III superiority trial. Eligibility criteria include histologically confirmed newly diagnosed glioblastoma and a performance status ≥70. Approximately a total of 750 patients will be enrolled and randomized 1:1. Stratification factors include institution, age, Karnofsky performance status and extent of surgery. The primary objective of this study is to compare overall survival in patients receiving marizomib in addition to standard of care (TMZ/RT→TMZ) with patients receiving standard treatment only. The testing strategy specifies the determination of this objective in both the intent-to-treat population and the subgroup of patients with tumors harboring an unmethylated MGMT promoter. Secondary endpoints include progression-free survival, safety, neurocognitive function and quality of life. The study is accompanied by a translational research program. The study will be opened at 50 EORTC sites in Europe and done as an intergroup collaboration with the Canadian Cancer Trials Group (CCTG) with 25 sites in Canada and additional sites in the US. Patient enrolment started in June 2018 and as of January 29, 2019, a total of 85 patients have been randomized. An update on the enrolment status will be provided at the ASCO conference. Clinical trial information: NCT03345095.

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