Phase I Study Methodology in Head and Neck Oncology

2011 ◽  
pp. 307-315
Author(s):  
Christophe Le Tourneau ◽  
Lillian L. Siu
Keyword(s):  
Phase I ◽  
Head And Neck ◽  
Phase I Study ◽  
Head And Neck Oncology ◽  
Study Methodology

Phase I Study Methodology in Head and Neck Oncology

2016 ◽  
pp. 731-742
Author(s):  
Aaron Hansen ◽  
Christophe Le Tourneau
Keyword(s):  
Phase I ◽  
Head And Neck ◽  
Phase I Study ◽  
Head And Neck Oncology ◽  
Study Methodology

scholarly journals Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1537 ◽  
Author(s):  
Julie E. Bauman ◽  
James Ohr ◽  
William E. Gooding ◽  
Robert L. Ferris ◽  
Umamaheswar Duvvuri ◽  
...  
Keyword(s):  
Phase I ◽  
Head And Neck ◽  
Phase I Study ◽  
Resistance Mechanism ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Intrinsic Resistance ◽  
Immune Biomarkers ◽  
Pathway Inhibition ◽  
Recommended Phase Ii Dose

Cetuximab, an anti-EGFR monoclonal antibody (mAb), is approved for advanced head and neck squamous cell carcinoma (HNSCC) but benefits a minority. An established tumor-intrinsic resistance mechanism is cross-talk between the EGFR and hepatocyte growth factor (HGF)/cMet pathways. Dual pathway inhibition may overcome cetuximab resistance. This Phase I study evaluated the combination of cetuximab and ficlatuzumab, an anti-HGF mAb, in patients with recurrent/metastatic HNSCC. The primary objective was to establish the recommended Phase II dose (RP2D). Secondary objectives included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Mechanistic tumor-intrinsic and immune biomarkers were explored. Thirteen patients enrolled with no dose-limiting toxicities observed at any dose tier. Three evaluable patients were treated at Tier 1 and nine at Tier 2, which was determined to be the RP2D (cetuximab 500 mg/m2 and ficlatuzumab 20 mg/kg every 2 weeks). Median PFS and OS were 5.4 (90% CI = 1.9–11.4) and 8.9 (90% CI = 2.7–15.2) months, respectively, with a confirmed ORR of 2 of 12 (17%; 90% CI = 6–40%). High circulating soluble cMet levels correlated with poor survival. An increase in peripheral T cells, particularly the CD8+ subset, was associated with treatment response whereas progression was associated with expansion of a distinct myeloid population. This well-tolerated combination demonstrated promising activity in cetuximab-resistant, advanced HNSCC.

Phase I Study of S-1 plus Nedaplatin in Patients with Advanced/Recurrent Head and Neck Cancer

Chemotherapy ◽  
2010 ◽  
Vol 56 (6) ◽  
pp. 453-458 ◽  
Author(s):  
Yasunao Kogashiwa ◽  
Kohichi Yamauchi ◽  
Hiroshi Nagafuji ◽  
Takehiro Matsuda ◽  
Toshihito Tsubosaka ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase I Study ◽  
Recurrent Head

Phase I study of concurrent carboplatin and radiotherapy in previously untreated patients with stage III and IV head and neck cancer

Head & Neck ◽  
1991 ◽  
Vol 13 (3) ◽  
pp. 217-222 ◽  
Author(s):  
David Osoba ◽  
Albino D. Flores ◽  
John H. Hay ◽  
Frances Wong ◽  
Maureen Maher
Keyword(s):  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase I Study ◽  
Stage Iii

A phase I study of cisplatin, tirapazamine and accelerated re-irradiation in unresectable recurrent head and neck cancer

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 5511-5511 ◽  
Author(s):  
E. E. W. Cohen ◽  
D. Rosine ◽  
E. Loh ◽  
D. J. Haraf ◽  
E. E. Vokes ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase I Study ◽  
Recurrent Head

Phase I study of panitumumab + chemoradiotherapy (CRT) for head and neck cancer (HNC)

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 6007-6007 ◽  
Author(s):  
L. J. Wirth ◽  
M. R. Posner ◽  
R. B. Tishler ◽  
R. I. Haddad ◽  
J. R. Clark ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase I Study

Phase I study of ridaforolimus with cetuximab for patients with advanced non-small cell lung cancer (NSCLC), colorectal cancer, and head and neck cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8075-8075
Author(s):  
Angela Marie Taber ◽  
Humera Khurshid ◽  
Kimberly Perez ◽  
Ariel E. Birnbaum ◽  
Adam J. Olszewski ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Dose Level ◽  
Neck Cancer ◽  
Phase I Study ◽  
Mtor Inhibitor ◽  
Egfr Antibody

8075 Background: mTOR inhibition may overcome PI3K/AKT pathway mediated resistance to anti-EGFR therapy. We performed a phase I study to determine the dose-limiting toxicity (DLT) of ridaforolimus, an investigational oral mTOR inhibitor, in combination with the anti-EGFR antibody cetuximab. Methods: Patients with advanced NSCLC, colorectal cancer, and head and neck cancer that progressed after at least 1 prior regimen for metastatic disease were eligible. ECOG performance status 0-1. Patients with previously treated brain metastases that were stable for >3 months were eligible. Wild-type K-RAS was required in colon cancer. All patients received cetuximab 400 mg/m2 week 1 followed by 250 mg/m2 weekly. Three dose levels of ridaforolimus were planned: 20mg, 30mg, and 40mg daily, 5 days each week, on a 28-day cycle. Results: 12 patients were entered with NSCLC (n=7), colon cancer (n=4), and head and neck cancer (n=1). The median age was 58 (42-69). The median number of prior regimens for metastatic disease, by disease type, was NSCLC (n=3), colorectal (n=4), head & neck (n=4). Three patients completed the first dose level without DLT. Two of 3 patients at dose level 2 had dose-limiting mucositis. The first dose level was then expanded with six additional patients with NSCLC without any further dose-limiting toxicities. The recommended phase II dose of ridaforolimus is 20 mg daily, 5 days a week, in combination with cetuximab. Response and prolonged stable disease was demonstrated in NSCLC. Conclusions: The DLT of the combination of ridaforolimus and cetuximab is mucositis. The activity observed in heavily pretreated patients with NSCLC suggests that the combination of an mTOR inhibitor with an EGFR antibody merits further investigation in NSCLC. Clinical trial information: NCT01212627.

End-of-life health care utilization (EOLHCU) in patients with thoracic, head and neck cancers with or without phase I study participation at a single institution.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19153-e19153
Author(s):  
Dominic Min-Tran ◽  
Annika Gustafson ◽  
Keith D. Eaton ◽  
Elizabeth Trice Loggers ◽  
Cristina P. Rodriguez ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Phase I ◽  
Head And Neck ◽  
End Of Life ◽  
Phase I Study ◽  
Care Utilization ◽  
Study Participation ◽  
Quality Of Death

e19153 Background: Several retrospective studies suggest patients enrolled in clinical trials have more end-of-life health care utilization (EOLHCU). This is particularly concerning for phase I clinical trial participants who are known to have therapeutic misconceptions about the purpose and benefits of phase I clinical trial participation. Methods: We identified all phase I participants at the Seattle Cancer Care Alliance (SCCA) with thoracic, head and neck cancers (THNC) who died between July 1, 2014 and June 30, 2018(P1C). We compared them to 139 randomly selected THNC patients who died within the same time period without phase I study participation (NP1C). Patient records were abstracted from the electronic health record (and Epic Care Everywhere if patients received EOL care outside of SCCA). A chi-square test was used to compare categorial variables and t-tests were used for numerical variables. Results: 67 P1C patients were identified; 3 patients had no outside records at the end of life and were removed from the database. No statistically significant differences in gender, ethnicity, marital status, or form of insurance were found between the two groups. P1C patients were younger (median age of 62 (interquartile range (IQR) 55-69) vs. 66 (IQR 59-72), p=0.008) and had more lines of therapy from diagnosis until death (median 4 (IQR 1-3) vs. 2 (IQR 1-3), p=<0.0001). No difference in end-of-life care or quality of death metrics were found between the two groups, however a trend toward more referrals to palliative care were noted in phase I participants. (Table). Conclusions: At our center no differences in EOLHCU or quality of death parameters were seen in THNC patients who did or did not participate in phase I studies. [Table: see text]

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