A multicenter, randomized, open-label, phase II trial of erlotinib versus etoposide plus cisplatin with concurrent radiotherapy in unresectable stage III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutation.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8531-8531 ◽  
Author(s):  
Ligang Xing ◽  
Gang Wu ◽  
Lvhua Wang ◽  
Jian-Cheng Li ◽  
Jianhua Wang ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Phase Iii ◽  
Stage Iii ◽  
Stage Iiia ◽  
Open Label ◽  
Concurrent Radiotherapy ◽  
Unresectable Stage ◽  
Open Label Phase ◽  
Egfr Mutant

8531 Background: Concurrent chemoradiotherapy is the standard treatment for patients(pts) with unresectable stage IIIA/IIIB NSCLC. In EGFR mutant pts, tyrosine kinase inhibitor(TKI) exhibits clinical benefits over chemotherapy regimens in terms of efficacy and safety as well as specific enhancement of radiation effects. This multicenter, randomized, open-label, phase II trial aimed to compare the erlotinib and etoposide/cisplatin with concurrent radiotherapy (RT) in pts with EGFR-mutant. Methods: Histopathology/cytology confirmed stage IIIA/B unresectable NSCLC pts (age 18-75) with ECOG PS 0-1 and EGFR exon 19 or 21 mutation were included and randomized (1:1) into two arms: erlotinib (E) and etoposide/cisplatin (EP). E arm was treated with oral erlotinib (150mg/day for 2 years or till either disease progression or intolerable toxicities) and RT (200cGy/day, 5 days/week for 6 weeks from first day erlotinib). EP arm was treated with sequential etoposide (50 mg/m2 IV days 1-5, 29-33) and cisplatin (50mg/m2IV day 1,8, 29,36) and RT (from first day drug). Primary endpoint is progress free survival (PFS). Secondary endpoints are objective response rate(ORR), local control rate(LCR), overall survival(OS), quality of life(QoL) and safety. Results: 252 pts were screened, and 41 were enrolled into E(n=20) and EP(n=21) arms. Characteristics of age, sex, histologic type, N2, EGFR 19 and 21 mutation were well balanced in each arm. Comparing with EP, median PFS of E arm was significantly improved (27.86 vs 6.41 months; HR 0.053, 95% CI: 0.006-0.463; P<0.001). ORR and DCR were 60.0% vs. 38.1%( P=0.217), and 65% vs. 47.6%( P=0.350), respectively. Two arms had same incidence of adverse effects (CTCAE Grade≥1, 86.7%[13/15]), and most common sAE(Grade≥3) was rash (20%, 3/15) and hematological toxicity(26.7%, 4/15), respectively. Conclusions: In unresectable stage III EGFR mutant NSCLC pts, concurrent erlotinib/RT provides a statistically significant PFS improvement with well tolerability. These results warrant a phase III study to confirm. (RECEL, NCT01714908). Clinical trial information: NCT01714908.

Maintenance gefitinib (G) after chemoradiotherapy (CRT) in patients (pts) with unresectable stage IIIA/B non-small cell lung cancer (NSCLC): A phase II trial of the Minnie Pearl Cancer Research Network

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7188-7188
Author(s):  
J. R. Gray ◽  
D. R. Spigel ◽  
J. D. Hainsworth ◽  
E. Vazquez ◽  
J. D. Peyton ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Large Cell ◽  
Research Network ◽  
Stage Iii ◽  
Stage Iiia ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Ecog Ps

7188 Background: Concurrent CRT improves outcomes for pts with unresectable stage III NSCLC compared with radiation (RT) alone. The EGFR inhibitor G benefits select pts with advanced NSCLC. This multicenter community phase II trial examined the role of CRT followed by G for pts with unresectable stage III NSCLC. Methods: Theprimary endpoint was 2-year overall survival (OS) in pts with unresectable stage IIIA/B NSCLC (effusions, N3 mediastinal nodes >4 cm excluded) treated with CRT followed by G. Induction(I) treatment (tx): docetaxel (D) 40 mg/m2 IV and gemcitabine 800 mg/m2 IV D1, 8 Q 21D × 3 cycles. Pts without progressive disease (PD) began: D 20 mg/m2 IV and carboplatin (C) AUC = 1.5 IV weekly × 6 and RT 61.2 Gy, 1.8-Gy M-F weekly × 7 (starting 1 week prior to D/C). If no PD, pts received G 250 mg PO daily × 2 years or until PD. Eligibility:measurable disease, ECOG PS 0–1, informed consent. Intent to treat analysis. Results: One-hundred three pts were enrolled from 7/03 to 4/05. Baseline features: medianage 60 years (37–79); male/female 54%/46%; ECOG PS 0/1:26%/74%; adenocarcinoma (26%), squamous (32%), large cell (28%), mixed/not specified (14%); IIIA/B (46%/54%). Grade 3/4 toxicities were limited to ≤ 8% except for neutropenia (17%, during I) - with notx-related deaths. Complete/partial responses after I were seen in 1 pt/34 pts, respectively, for an overall response rate (RR) of 34% (95% CI 26%-44%). Forty-two pts (41%) had stable disease (SD) and 12% had PD (9 pts were unevaluable.) Seventy-four pts (72%) received D/C/RT which resulted in an overall RR of 44% (95% CI 35%-54%). Fifteen percent had SD. Fifty-six pts (54%) received G for a median of 28 weeks (1–107). Median PFS and OS are 9.9 and 15 months, respectively. After a median follow-up of 19 months, actuarial 1- and 2-year progression-free survival (PFS) is 41% and 12%, respectively. 1- and 2-year OS rates are 64% and 21%, respectively. Subset analyses by smoking, gender, histology, and stage are in progress. Conclusions: Maintenance G following CRT in unresectable NSCLC does not appear to improve survival. It is possible that further analysis may suggest a role for G in selected pts. [Table: see text]

A randomised, open-label phase II trial of afatinib versus cetuximab in patients with metastatic colorectal cancer

2014 ◽  
Vol 50 (18) ◽  
pp. 3136-3144 ◽  
Author(s):  
Tamas Hickish ◽  
Jim Cassidy ◽  
David Propper ◽  
Ian Chau ◽  
Stephen Falk ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Open Label ◽  
Open Label Phase

Silmitasertib (CX-4945) in combination with gemcitabine and cisplatin as first-line treatment for patients with locally advanced or metastatic cholangiocarcinoma: A phase Ib/II study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 312-312
Author(s):  
Mitesh J. Borad ◽  
Li-Yuan Bai ◽  
Ming-Huang Chen ◽  
Joleen M. Hubbard ◽  
Kabir Mody ◽  
...  
Keyword(s):  
Phase Ii ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Preliminary Evidence ◽  
Phase Iii ◽  
Response To Treatment ◽  
Open Label ◽  
Phase Ib ◽  
Open Label Phase ◽  
Almost All

312 Background: Silmitasertib (CX-4945), an oral small molecule inhibitor of casein kinase 2 (CK2), has exhibited preclinical antitumor activity and strong synergism with gemcitabine + cisplatin. We investigated the safety and efficacy of silmitasertib in combination with gemcitabine + cisplatin in patients with unresectable cholangiocarcinoma (CCA). Methods: S4-13-001 is a multicenter, open-label, phase Ib/II study of silmitasertib in combination with gemcitabine + cisplatin in patients with locally advanced or metastatic CCA. The phase Ib portion included dose-escalation, expansion, and exploratory cohorts of silmitasertib with doses ranging from 200 to 1000 mg bid (6 days for the escalation/expansion cohorts and 10 and 21 days’ continuous dosing for the exploratory cohorts). In the phase II portion patients received silmitasertib 1000 mg bid for 10 days in combination with gemcitabine + cisplatin on days 1 & 8 over a 21-day cycle. In this interim analysis, we present findings from the combined population of patients from the phase Ib and II portions of the study. Response to treatment was assessed by RECIST v1.1 every 6 weeks. Primary efficacy outcome measure was progression-free survival (PFS). ClinicalTrials.gov (NCT02128282). Results: A total of 87 patients were enrolled and received silmitasertib in the phase Ib (n=50) and phase II (n=37) portions of the study. Of these, 55 patients were evaluable for efficacy with details as follows: median PFS 11.1 (95% CI 7.6–14.7) months; median overall survival (OS) 17.4 (95% CI 13.4–25.7) months; overall response rate (ORR) 32.1%; and disease control rate (DCR) 79.3%. Almost all patients (79/87; 90.8%) evaluable for safety reported ≥1 treatment-related adverse event (TEAE). The most common TEAEs (all grades) with silmitasertib were diarrhea (65.5%), nausea (50.6%), vomiting (33.3%), fatigue (31.0%), and anemia (21.8%). The most common grade ≥3 TEAEs were diarrhea (13.8%), neutropenia (11.5%), nausea (9.2%), anemia (8.0%), and thrombocytopenia (8.0%). Eleven patients (12.6%) discontinued treatment due to TEAEs. Conclusions: Silmitasertib in combination with gemcitabine + cisplatin yields promising preliminary evidence of efficacy in patients with locally advanced or metastatic CCA. Based on these data a randomized phase III trial is planned. Clinical trial information: NCT02128282.

scholarly journals Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

2019 ◽  
Vol 10 (25) ◽  
pp. 6185-6190
Author(s):  
Seung Tae Kim ◽  
Sung Yong Oh ◽  
Jeeyun Lee ◽  
Jung Hun Kang ◽  
Hyun Woo Lee ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Second Line ◽  
Open Label ◽  
Second Line Therapy ◽  
Biliary Tract Cancers ◽  
Line Therapy ◽  
Open Label Phase

scholarly journals The Developing Regorafenib Eye drops for neovascular Age‐related Macular degeneration (DREAM) study: an open‐label phase II trial

2018 ◽  
Vol 85 (2) ◽  
pp. 347-355 ◽  
Author(s):  
Antonia M. Joussen ◽  
Sebastian Wolf ◽  
Peter K. Kaiser ◽  
David Boyer ◽  
Thomas Schmelter ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Age Related Macular Degeneration ◽  
Eye Drops ◽  
Open Label ◽  
Age Related ◽  
Open Label Phase
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