First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)

Conditions

colorectal cancer

Tetsuji Terazawa, Takeshi Kato, Masahiro Goto, Katsuya Ohta, Hironaga Satake et al. (21 authors)

The Oncologist2022-08-102 citations

Phase II study of panitumumab monotherapy in chemotherapy-naïve frail or elderly patients with unresectable, <i>RAS</i> wild type colorectal cancer: OGSG 1602, survival update data.

Shingo Noura, Takeshi Kato, Tetsuji Terazawa, Masahiro Goto, Katsuya Ohta et al. (21 authors)

Journal of Clinical Oncology2021-05-20

10.1200/jco.2021.39.15_suppl.3558

Phase II study of panitumumab monotherapy in chemotherapy-naïve frail or elderly patients with unresectable, <i>RAS</i> wild-type colorectal cancer: OGSG 1602.

Katsuya Ohta, Takeshi Kato, Masahiro Goto, Tetsuji Terazawa, Shingo Noura et al. (21 authors)

Journal of Clinical Oncology2020-02-012 citations

10.1200/jco.2020.38.4_suppl.106

First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602.

Terazawa T, Kato T, Goto M, Sakai D, Kurokawa Y, Shimokawa T, Matsubara Y, Satoh T.

2019-06-25

10.1186/s12885-019-5821-z

Interventions

Panitumumab 6mg/kg intravenously every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed CRC that is not a candidate for curative surgical resection 2) Wild Type RAS 3) Patients with metastatic colorectal cancer have received no previous systemic chemotherapy. 4) Age >= 76 years old or age >= 65 who were not deemed to be candidates for combination chemotherapy in the judgment of the treating investigator 5) Measurable disease according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria (version 1.1) 6) Adequate organ function 7) Life expectancy of at least 90 days from enrollment 8) Written informed consent prior to study-specific screening procedure 9) Who had not received EGFR antibody

Exclusion criteria

Exclusion criteria: 1) Uncontrolled diarrhea 2) Symptomatic Interstitial pneumonia or pulmonary fibrosis 3) Previous palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks 4) History of other malignancy with a disease-free interval <1 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection) 5) Active infections 6) Serious complications Uncontrolled diabetes mellitus, Uncontrolled gastrointestinal bleeding, Heart failure(and over NYHA ll), hepatic failure and so on 7) History of serious anaphylaxis 8) Requires continuous treatment with systtematic steroids 9) Psychiatric disability that would preclude study compliance 10)Pregnant or lactating females, and males and females unwilling to use contraception 11) HBs antigen positive 12) Otherwise determined by the investigator to be unsuitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Disease control rate (DCR)	—

Secondary

Measure	Time frame
Response Rate (RR) Progression free survival (PFS) Overall survival (OS) Time to Treatment Failure (TTF) Safety : the rate of Grade3/4 toxicity	—

Countries

Japan

Contacts

Public ContactTetsuji Terazawa

Osaka Medical College Hospital Chemotherapy Center

terasawat@poh.osaka-med.ac.jp072-683-1211

Outcome results

None listed