PBP (Panitumumab beyond Progression)

JRCT ID: jRCTs041180113

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 18/08/2017
• Target sample size: 55
• Study type: Interventional
• Intervention(s): Second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor

Outcome(s)

• Primary Outcome: 6-month progression-free survival (PFS) rate

Secondary Outcome

Overall survival (OS)
Progression-free survival (PFS)**
Time to treatment failure (TTF)
Overall response rate (ORR)
Disease control rate (DCR)
Relative dose intensity (RDI)
Safety and tolerability
Gene mutation status

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer
2)Refractory tumor with measurable disease by RECIST 1.1 that has progressed, or appearance of evaluable new lesion after the first line therapy with FOLFOX+panitumumab
3)Age >=20 years at the time of informed consent
4)ECOG performance status (PS) of 0-2
5)Written informed consent prior to study-specific screening procedures
6)Life expectancy of at least 90 days
7)Withdrawal from the first-line chemotherapy with FOLFOX + panitumumab for RAS wild-type advanced or metastatic colorectal cancer due to intolerable toxicity excluding to panitumumab alone or progressive disease
8)Adequate organ function according to following laboratory values obtained within 14 days before enrollment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
i)Neutrophil count:>=1500/mm3
ii) Platelet count: >=10.0 x 104/mm3
iii) Hemoglobin: >=8.0 g/dL
iv) Total bilirubin: <=1.5 mg/dL
v) AST, ALT: <=100 IU/L (<=200 IU/I if liver metastases present)
vi) Serum creatinine: <=1.5 mg/dL
9)Confirmed RAS wild type tumor at the time of the first-line therapy

Exclude criteria

1)History of other malignancy with a disease-free interval <5 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)
2)With massive pleural effusion or ascites requiring intervention
3)Radiological evidence of brain tumor or brain metastases
4)Active infection including hepatitis
5)Any of the following complication:
i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus)
ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure)
iii) Interstitial pneumonia or pulmonary fibrosis
iv) Uncontrolled diabetes mellitus
v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)
6)Any of the following medical history:
i) Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes
ii) Serious hypersensitivity to any of the study drugs
iii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency
7)Previous treatment with irinotecan hydrochloride
8)Current treatment with atazanavir sulfate
9)Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
10)Pregnant and lactating females, and males and females unwilling to use contraception
11)Requires continuous treatment with systemic steroids
12)Psychiatric disability that would preclude study compliance
13)Otherwise determined by the investigator to be unsuitable for participation in the study

Related Information

• Primary Sponsor: Nagata Naoki
• Source(s) of Monetary Support: Takeda Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000026817