Prospective evaluation of quality of life (QOL) during a phase I/II study of adjuvant chemotherapy with image-guided high-precision radiotherapy for completely resected gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 164-164 ◽  
Author(s):  
Rebecca Barbara Goody ◽  
Helen Mackay ◽  
Bethany Pitcher ◽  
Amit M. Oza ◽  
James D. Brierley ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Standard Dose ◽  
Nausea And Vomiting ◽  
Adjuvant Chemoradiotherapy ◽  
Median Difference ◽  
Image Guided ◽  
Patient Reported ◽  
Resected Gastric Cancer

164 Background: Adjuvant chemoradiotherapy improves overall and relapse free survival in patients with completely resected gastric cancer, but confers toxicity. This prospective phase I/II clinical trial assessed the toxicity, efficacy and QOL when adding bi-weekly cisplatin to adjuvant chemoradiotherapy with infusional 5-fluorouracil (5-FU). Phase I data showed promising outcomes with acceptable toxicity. Methods: Treatment comprised 45 Gy in 25 fractions of image-guided 3D-CRT or IMRT concurrently with weeks 3-7 of 12 weeks of infusional 5-FU. Cisplatin (up to bi-weekly) was added in a standard dose-escalation protocol. Patients completed the EORTC QLQ-C30 at baseline, end of radiotherapy, 4 weeks post chemotherapy and at 1 and 2 years. Results: Among 55 participants (mean age 54, range 28 to 77; 55% male; median follow-up 3.03 years), QOL compliance ranged from 93% at baseline to 70% at 4 weeks post-treatment. Maximal tolerable dose of cisplatin was 40 mg/m2 bi-weekly for 4 cycles. OS and DFS rates are 85% and 74% respectively at 2 years. Mean scores for global QOL (median difference = -25, p < 0.0001), role and social functioning, fatigue, nausea and vomiting, and appetite declined at completion of radiation; physical functioning showed a statistically significant decline of borderline clinical importance (median difference = -6.7, p <.0001). All scales recovered by 4 weeks after chemotherapy except fatigue, which returned to baseline by one year. Conclusions: Adjuvant gastric chemoradiotherapy incorporating cisplatin worsened global QOL, fatigue, nausea and vomiting and appetite. Most scales recovered by 4 weeks post-chemotherapy. This regimen is tolerable not only by observer rated toxicity, but also by patient reported QOL measures. Clinical trial information: NCT00188266.

scholarly journals DCVax®- DIRECT: autologous activated dendritic cells for image guided intra-tumoral vaccination in patients with solid tumors - a phase I/II clinical trial in progress

2013 ◽  
Vol 1 (Suppl 1) ◽  
pp. P238
Author(s):  
Vivek Subbiah ◽  
Ravi Murthy ◽  
Chitra Hosing ◽  
Indresh Kaur ◽  
Gerald Falchook ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dendritic Cells ◽  
Phase I ◽  
Solid Tumors ◽  
Image Guided

Preliminary results of phase I clinical trial of high doses of seleno-L-methionine (SLM) in sequential combination with axitinib in previously treated and relapsed clear cell renal cell carcinoma (ccRCC) patients.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 660-660 ◽  
Author(s):  
Rohan Garje ◽  
James A. Brown ◽  
Kenneth Gerard Nepple ◽  
Laila Dahmoush ◽  
Andrew Bellizzi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Standard Dose ◽  
Treatment Resistance ◽  
Progression Free Survival ◽  
Drug Uptake ◽  
Dose Finding ◽  
High Dose ◽  
Cell Renal Cell Carcinoma ◽  
Metastatic Rcc

660 Background: The overexpression of hypoxia induced factor 1a/2a in ccRCC leads to up-regulation of vascular endothelial growth factor (VEGF) that results in increased angiogenesis, tumor metastasis, and treatment resistance. Using several preclinical xenograft models, it has been demonstrated that therapeutic doses of the selenium-containing molecules, seleno-L-methionine (SLM) and methylselenocysteine (MSC) caused enhanced degradation of HIF1α/2α, down-regulation of oncogenic miRNA-210 and 155, up-regulation tumor suppressor miRNA-664 and LET-7b, and stabilization of tumor vasculature, yielding higher tumor drug uptake and protection from toxic side effects when combined with chemotherapeutic and VEGF-targeted agents. Methods: This is a phase I (3+3 design) dose finding trial of SLM (2500, 3000 or 4000 µg) given orally twice daily for 14 days, followed by once a day in combination with standard dose axitinib to patients with metastatic RCC. Primary endpoint is safety. Secondary endpoint is efficacy including overall response rate (ORR), progression free survival (PFS) and overall survival (OS). Results: To date, 12 evaluable patients (pts) with metastatic RCC who progressed on one or more prior lines of treatment were enrolled. The first 3 pts were treated at 4000 µg, the second and third 3 pts were treated at 2500 and 3000 µg respectively. Additional 3 pts were added to 4000 µg. No dose limiting toxicity (DLT) was seen. Most common AEs included fatigue, diarrhea, hypertension, nausea, anorexia, cough, proteinuria and weight loss. Of the 4000 µg cohort, 2 pts achieved CR with ongoing responses at 31 and 29 months, 1 pt had PR for 24 months and 1 had PD at 3 months, 2 pts are not assessed yet. Of the 2500 µg cohort, 1 pt with ongoing PR for 21 months, 1 pt had stable disease for 6 months, and 1 pt had PD at 2 months. The 3000 µg cohort, one pt has ongoing PR for 12 months; another pt had PR lasting 10 months, the 3rd pt had SD for 4 months. Conclusions: High dose SLM is safe in combination with axitinib, with promising efficacy. Further data including biomarkers will be presented at the meeting. Clinical trial information: NCT02535533.

A pilot study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a phase I clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6587-6587 ◽  
Author(s):  
Rui Qin ◽  
Amylou C. Dueck ◽  
Daniel Satele ◽  
Julian R. Molina ◽  
Charles Erlichman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Adverse Events ◽  
Phase I ◽  
Patient Reported Outcomes ◽  
Point Of View ◽  
Phase I Clinical Trial ◽  
Phase I Clinical Trials ◽  
Patient Reported

6587 Background: Recently the Patient-Reported Outcomes version of the CTCAE was developed to augment clinically graded adverse events with information reported directly by patients on clinical trials (Basch, 2009). The validation and potential application of PRO-CTCAE in phase I clinical trials are of great interest as toxicity is the primary endpoint. Methods: Selected PRO-CTCAE items (21 items measuring 12 symptomatic adverse events) corresponding to the major adverse events required to be graded clinically were collected in an ongoing phase I clinical trial of weekly cilengitide and paclitaxel in patients with advanced solid malignancies (NCT01276496). PRO-CTCAE was administered in a paper booklet by a clinical research associate prior to treatment on days 1, 8 and 15 of their regular visits. These PRO-CTCAE items were summarized descriptively in comparison to clinician-assessed CTCAE ver 4.0 (NCI, 2009) during the first cycle. As a pilot study to assess feasibility of PRO-CTCAE in phase I trials, PRO-CTCAE was not intended for determination of dose-limiting toxicity. Results: Twelve patients were accrued to two separate doses of cilengitide and paclitaxel. The median age was 56 (range 36—67) and half of patients were female. All patients had an ECOG performance score <= 1. Over 90% of patients had received prior surgery and chemotherapy. All but one patient completed weekly PRO-CTCAE during the first cycle, the only patient refused to complete weeks 2 and 3 did not give a reason. PRO-CTCAE captured most of the symptomatic adverse events reflected in clinician-assessed CTCAE. Some symptomatic adverse events were not reported clinically by CTCAE but were reported by patients by PRO-CTCAE. Overall, PRO-CTCAE items indicated slightly more severe degree of symptoms experienced by patients than those reported in CTCAE. Conclusions: This is the first study that PRO-CTCAE items were integrated within regular study visits in a phase I trial. The administration of PRO-CTCAE has been proved feasible and fruitful, providing consistent and enhanced symptomatic toxicity from the patient point of view. The addition of PRO-CTCAE did not significantly increase patient burden. Clinical trial information: NCT01276496.

scholarly journals Phase I clinical trial of peptide vaccination with URLC10 and VEGFR1 epitope peptides in patients with advanced gastric cancer

2013 ◽  
Vol 44 (3) ◽  
pp. 662-668 ◽  
Author(s):  
YOSHIE HIGASHIHARA ◽  
JUNKO KATO ◽  
AKIHITO NAGAHARA ◽  
KENTARO IZUMI ◽  
MASAE KONISHI ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Advanced Gastric Cancer ◽  
Phase I Clinical Trial ◽  
Peptide Vaccination

scholarly journals Mo1559 Phase I Clinical Trial of Peptide Vaccination With Urlc10 and VEGFR1 Epitope Peptides in Patients With Advanced Gastric Cancer

2012 ◽  
Vol 142 (5) ◽  
pp. S-628
Author(s):  
Yoshie Higashihara ◽  
Junko Kato ◽  
Nobuko Serizawa ◽  
Tomohiro Kodani ◽  
Masae Konishi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Advanced Gastric Cancer ◽  
Phase I Clinical Trial ◽  
Peptide Vaccination

Neoadjuvant nivolumab monotherapy in patients with resectable gastric cancer: Preliminary results from a multicenter study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4026-4026
Author(s):  
Shuji Takiguchi ◽  
Kohei Shitara ◽  
Noriaki Takiguchi ◽  
Seiji Ito ◽  
Mitsugu Kochi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
The Other ◽  
Stage I ◽  
Stage Iii ◽  
R0 Resection ◽  
Safety And Efficacy ◽  
Preliminary Results ◽  
Clinical Trial Information

4026 Background: In recent years, several studies suggest that neoadjuvant treatment improve outcomes of patients with resectable advanced gastric cancer (GC). In addition, nivolumab has demonstrated clinical efficacy in multiple types of advanced cancer, and the efficacy of neoadjuvant nivolumab monotherapy has been suggested in a past clinical trial in patients with resectable non-small cell lung cancer (NSCLC). Therefore, this phase I study was planned to evaluate the safety and efficacy of neoadjuvant nivolumab monotherapy in patients with resectable GC or NSCLC. Here we report preliminary results from GC patients. Methods: This study is a phase I, multicenter, open-label, single arm study to evaluate the safety and efficacy of neoadjuvant nivolumab monotherapy in patients with resectable GC (stage I or II [cT2 or more advanced for both], or stage III) before standard surgery. Nivolumab 240 mg was administered twice every two weeks. The primary endpoint is safety. Efficacy endpoints include major pathological response (MPR) defined as residual disease < 10% and the response of primary lesion, and surgical endpoints include proportion of patients undergoing surgery with curative intent and R0 resection rate. Biomarkers such as PD-L1 expression and MSI status are also evaluated. Results: From November 2018 to December 2019, 31 GC patients were enrolled into this study. The median age was 69 years (range, 44-84) and 21 patients (67.7%) were men. According to UICC 8th, clinical stage was stage I in 7 patients (22.6%), stage IIA in 0 patients (0%), stage IIB in 14 patients (45.2%), and stage III in 10 patients (32.3%). MSI status was high in 7 patients (22.6%), low in 4 patients (12.9%), and stable in 20 patients (64.5%). Treatment-related adverse events (TRAEs) occurred in 7 patients (22.6%). The most frequent TRAE was rash which occurred in 2 patients (6.5%); the other TRAEs occurred in 1 patient each. Asymptomatic lipase increased was the only grade 3 TRAE; the other TRAEs were all grade 1 or 2 with no new safety signal. All enrolled patients completed 2 doses of nivolumab. Five patients (16.1%) had MPRs, of whom 1 patient had pathological complete response (pCR). Four of 5 MPRs, 1 pCR included, was observed in 7 MSI-H patients (57.1%) and the remaining case of MPR was observed among 20 MSS patients (5%), whereas no MPRs was achieved in 4 MSI-L patients. Among the 31 patients, 30 patients underwent surgery. The remaining 1 patient discontinued the study before surgery due to disease progression. A total of 27 patients (90%) had R0 resection. Conclusions: Neoadjuvant nivolumab monotherapy showed acceptable safety profile and antitumor activity in patients with resectable GC. Recurrence free survival and overall survival in these patients are under follow-up. Clinical trial information: JapicCTI-183895. Clinical trial information: JapicCTI-183895.

scholarly journals Seven-day capecitabine plus docetaxel and oxaliplatin regimen for the treatment of advanced gastric cancer: A phase-I clinical trial

2017 ◽  
Vol 6 (4) ◽  
pp. 622-626
Author(s):  
Rong Liang ◽  
Yan Lin ◽  
Yongqiang Li ◽  
Qian Li ◽  
Chunling Yuan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Advanced Gastric Cancer ◽  
Phase I Clinical Trial
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