A randomized phase 2 study assessing the efficacy and safety of levofloxacin added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer(T-CORE2201)

JRCT ID: jRCTs021230005

Registered date:19/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancretic cancer
• Date of first enrollment: 19/05/2023
• Target sample size: 140
• Study type: Interventional
• Intervention(s): Levofloxacin treatment is added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer.

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival,Response rate,Disease control rate,Overall response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Histologically confirmed as adenocarcinoma of the pancreas.
2) Unresectable or advanced pancreatic cancer (Stage IV) or postoperative recurrent pancreatic cancer (No limitation on the period from the operation to the recurrence).
3) Patients who will receive GEM plus nabPTX combination therapy as the first line chemotherapy.
4) ECOG performance status 0 or 1.
5) Over 20 years old and under 80 years old.
6) Patients who have ability to understand the informed consent document for this clinical trial and who have signed to the informed consent document.
7) Fulfill the following hematological and biochemical data within 14 days before the registration.
a) Leucocyte: >-1500/mm3
b) Hemoglobin:>-8.0 g/dl
c) Platelets: 100,000/mm3
d) Total Bil: <-2.0mg/dl
e) Serum AST(GOT), serum ALT(GPT):<-100 U/L
f) Serum creatinine:<-1.5 mg/dl
g) One or more measurable lesions confirmed by CT or other imaging within 30 days before the registration. For patients who had received the radiation therapy, the new target lesions appeared after the irradiation or target lesions outside the irradiation field will be included.
h) Patients who are estimated to survive for 60 days or more since the registration.
i) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.

Exclude criteria

1) Patients who had received Gem or nabPTX within 6 months before the registration. (If patients received GEM/nabPTX combination therapy as a preoperative chemotherapy for the purpose of conversion therapy, these patients can be enrolled if more than 6 months have passed since the preoperative chemotherapy had completed)
2) Patients who had received the radiation therapy within a month before the protocol therapy begins.
3) Patients who had synchronous double cancers other than the pancreatic cancer that require the aggressive treatment. (Metachronous double cancer with the disease-free interval within 5 years before the registration)
4) Patients with the gastrointestinal disorders that interfere with the absorption, the metabolism or the excretion of the levofloxacin.
5)Patients who received antibiotics for 5 or more days within a month before the registration.
6) Patients with allergy for the new quinolone antibiotics.
7) Patients who are taking warfarin regularly.
8) Patients who are taking the phenyl acetic acid non-steroidal anti-inflammatory drugs or propionic acid non-steroidal anti-inflammatory drugs regularly.
9) Patients who are taking the delamanid regularly.
10) Patients with severe complications such as gastrointestinal bleeding, gastrointestinal paresthesia, ileus, interstitial pneumoniae or pulmonary fibrosis, treatment required ischemic heart disease or arrhythmia, heart failure, renal dysfunction, liver cirrhosis, glaucoma or diabetes mellitus.
11) Patients who received a blood transfusion within 2 weeks before the registration.
12) Patients with symptomatic CNS metastases.
13) Patients receiving continuous systemic steroid administration.
14) Patients with the active infection.(Patients with the fever of 38 degrees celcius or higher due to the infection)
15) Patients with the uncontrolled hepercalcemia.
16) Patients with the uncontrolled hypertension.
17) Patients with the data with HBs antigen-positive or HCV antibody-positive. (However, HBs antigen-positive cases controlled with the nucleic acid analogues and confirmed to be HBV-DNA-negative can be enrolled to this study)
18) patients who have psychosis or psychiatric symptoms and are judged to be difficult to
Participate in this study.
19) Pregnant women, lactating women and women who may be pregnant. Patients who are unwilling to use contraception.
20) Patients unable to comply with clinical trial procedures, including the oral administration of levofloxacin and the routine visits. Patients who have any medical condition that could significantly affect the interpretation of clinical trial data.

Related Information

• Primary Sponsor: Ishioka Chikashi
• Source(s) of Monetary Support: Tohoku Clinical Oncology Research and Education Society(T-CORE)