Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— GCRP  

Official title:

Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03498326
• Other study ID #: SAHZhejiangU-GCRP
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2018
• Est. completion date: March 31, 2030

Study information

• Verified date: May 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Tingbo Liang
• Phone: 13666676128
• Email: liangtingbo[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.

Description:

We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 18 years old and above.

2. Surgery for R0 resection.

3. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.

4. Eastern Cooperative Oncology Group score 0-2 points.

5. Blood routine: The neutrophil count is at least 1.5*10^9/ml, and the platelet count is at least 100*10^9/ml.Hemoglobin is at least 80g/L.

6. Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine = 1.2 mg/dL.

Exclusion Criteria:

1. Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).

2. Surgery for pancreatic cancer fails to reach the R0 resection criteria.

3. Pancreatic cancer received radiotherapy before surgery.

4. Malignant brain metastases.

5. There are other serious cancer history.

6. Active infection, severe diarrhea.

7. Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug History of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.
• Gemcitabine
the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period.

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	the duration between the date of surgery and the date of disease relapse	Up to approximately 60 months
Secondary	overall survival	the duration between the date of surgery and the date of patient death	Up to approximately 60 months
Secondary	Carbohydrate antigen 19-9	serum Carbohydrate antigen 19-9 level	Up to approximately 36 months
Secondary	Quality of Life	assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score	Up to approximately 60 months
Secondary	Common Toxicity Criteria for Adverse Effects	according to Common Toxicity Criteria for Adverse Effects version 4	Up to approximately 12 months