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

Primary Purpose

Pancreatic Cancer, Chemotherapy Effect

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, gemcitabine, celecoxib, R0 resection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old and above.
Surgery for R0 resection.
The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.
Eastern Cooperative Oncology Group score 0-2 points.
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.
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:

Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).
Surgery for pancreatic cancer fails to reach the R0 resection criteria.
Pancreatic cancer received radiotherapy before surgery.
Malignant brain metastases.
There are other serious cancer history.
Active infection, severe diarrhea.
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.

Sites / Locations

the second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

gemcitabine

gemcitabine plus celecoxib

Arm Description

one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.

the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period.

Outcomes

Primary Outcome Measures

disease free survival

the duration between the date of surgery and the date of disease relapse

Secondary Outcome Measures

overall survival

the duration between the date of surgery and the date of patient death

Carbohydrate antigen 19-9

serum Carbohydrate antigen 19-9 level

Quality of Life

assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score

Common Toxicity Criteria for Adverse Effects

according to Common Toxicity Criteria for Adverse Effects version 4

Full Information

NCT ID

NCT03498326

First Posted

April 2, 2018

Last Updated

May 27, 2018

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03498326

Brief Title

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

Acronym

GCRP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Recruiting

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

March 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Chemotherapy Effect

Keywords

pancreatic cancer, gemcitabine, celecoxib, R0 resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gemcitabine

Arm Type

Experimental

Arm Description

one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.

Arm Title

gemcitabine plus celecoxib

Arm Type

Experimental

Arm Description

the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

celecoxib

Intervention Description

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.

Primary Outcome Measure Information:

Title

disease free survival

Description

the duration between the date of surgery and the date of disease relapse

Time Frame

Up to approximately 60 months

Secondary Outcome Measure Information:

Title

overall survival

Description

the duration between the date of surgery and the date of patient death

Time Frame

Up to approximately 60 months

Title

Carbohydrate antigen 19-9

Description

serum Carbohydrate antigen 19-9 level

Time Frame

Up to approximately 36 months

Title

Quality of Life

Description

assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score

Time Frame

Up to approximately 60 months

Title

Common Toxicity Criteria for Adverse Effects

Description

according to Common Toxicity Criteria for Adverse Effects version 4

Time Frame

Up to approximately 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old and above. Surgery for R0 resection. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies. Eastern Cooperative Oncology Group score 0-2 points. 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. 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: Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma). Surgery for pancreatic cancer fails to reach the R0 resection criteria. Pancreatic cancer received radiotherapy before surgery. Malignant brain metastases. There are other serious cancer history. Active infection, severe diarrhea. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tingbo Liang

Phone

13666676128

liangtingbo@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xueli Bai

shirlybai@zju.edu.cn

Facility Information:

Facility Name

the second affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Chen, MD,PhD

Phone

+8613857168284

chen_qi@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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