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A multicenter, phase II trial to investigate the safety and efficacy of Panitumumab and Irinotecan in Neo Ras Wild type metastatic colorectal cancer patients (C-PROWESS study)

C-PROWESS study (C-PROWESS study)

Shinozaki Eiji

The Cancer Institute Hospital of JFCR

3-8-31 Ariake, Koto-ku, Tokyo

eiji.shinozaki@jfcr.or.jp

Osumi Hiroki

The Cancer Institute Hospital of JFCR

3-8-31 Ariake, Koto-ku, Tokyo

+81-3-3520-0111

hiroki.osumi@jfcr.or.jp

Not Recruiting

Jan. 20, 2022

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

Patients eligible for inclusion in this study have to meet all of the following criteria:
1) Must give written Informed Consent
2) Histologically proven diagnosis of colorectal adenocarcinoma
3) Advanced or recurrent colorectal cancer (excluding appendix and anal canal cancer)
4) Age>= 20 years
5) Eastern Cooperative Oncology Group (ECOG) performance status <= 2
6) At least one measurable lesion according to RECIST version 1.1 criteria evaluated by CT or MRI within 28 days before registration
7) RAS mutation (MT) (KRAS/NRAS exon 2, 3, or 4 MT) confirmed by tumor histology prior to the study enrollment
8) Must have had documentation of the RAS WT confirmed within 28 days from test result date by ctDNA analysis using the OncoBEAM (TM) RAS CRC KIT
9) Must have confirmed refractory or intolerant to previous treatments with chemotherapies including fluoropyrimidines, oxaliplatin, or irinotecan (irinotecan is applied to refractory only), regardless of prior treatment with trifluridine tipiracil hydrochloride, regorafenib, or angiogenesis inhibitors.
10) Life expectancy of at least 60 days
11) Adequate organ functions (bone marrow, liver, renal functions) as defined by the following laboratory values obtained within 14 days prior to the study enrollment:
a.Absolute neutrophil count >= 1500/ mm3
b.Platelets >= 75000/mm3
c.Serum total bilirubin <= 1.5 mg/dL
d.Serum AST(GOT) and ALT(GPT) <= 100 U/L(except for patients with tumor involvement of the liver who must have AST and ALT <= 200 U/L)
e.Serum creatinine <= 1.5 mg/dL

Patients eligible for inclusion in this study must not meet any of the following criteria:
1) Evidence of BRAF V600E MT by tumor histology.
2) Treated with blood transfusion, blood products, or hematopoietic factor products such as Granulocyte Colony Stimulating Factor within 7 days prior to enrollment in this study.
3) Have a history of severe drug hypersensitivity or severe drug allergy
4) Active infection (fever of 38 degree or higher due to infection).
5) Ascites, pleural effusion, or pericardial effusion requiring continuous drainage.
6) Uncontrolled diabetes mellitus.
7) Uncontrolled hypertension.
8) Patients who have been treated with any of the following treatments prior to starting study drug:
a.Extensive surgery <= 4 weeks prior to starting study drug (e.g., surgical treatment with organ resection, excluding colostomy)
b.Proctocolectomy <= 2 weeks prior to starting study drug
c.Any chemotherapy <= 2 weeks prior to starting study drug
d.Radiotherapy <= 2 weeks prior to starting study drug
9) Clinically significant electrocardiographic abnormality or clinically significant cardiovascular accidents within 6 months prior to study enrollment, including myocardial infarction, severe unstable angina, or New York Heart Association functional classification class III or IV congestive heart failure.
10) Patients with severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema).
11) History of clinically significant mental disorder or central nervous system disorder.
12) Symptomatic brain metastasis or clinically suspected brain metastasis upon symptoms.
13) Diarrhea that interferes with daily life.
14) Intestinal paralysis, intestinal obstruction.
15) Co-existing active malignancies.
16) Pregnant or lactating women; women of childbearing potential or men with women partners of childbearing potential who are unwilling to use a highly effective method of contraception or avoid intercourse during and upon completion of the study. 17) Patients who are judged by the site physician to be inappropriate for this study.
18) Patients who have been treated with EGFR inhibitors prior to starting study drug.

Both

Neo Ras Wild type metastatic colorectal cancer

Combination therapy of panitumumab plus irinotecan: Patients receive panitumumab (intravenous dose of 6 mg/kg) plus intraveous infusion of irinotecan of 150 mg/m2 (body surface area). Treatment cycles are repeated every 2 weeks until disease progression, unacceptable adverse events, or withdrawal of consent.

Response Rate

Overall survival, Progression free survival, Disease control rate, Adverse event

+81-3-3542-2511

Dec. 23, 2021

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