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

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ClinicalTrials.gov Identifier: NCT03498326
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Chemotherapy Effect Drug: Gemcitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2030


Arm Intervention/treatment
Experimental: gemcitabine
one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.
Drug: Gemcitabine
One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.

Experimental: gemcitabine plus celecoxib
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.
Drug: 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.
Other Name: celecoxib




Primary Outcome Measures :
  1. disease free survival [ Time Frame: Up to approximately 60 months ]
    the duration between the date of surgery and the date of disease relapse


Secondary Outcome Measures :
  1. overall survival [ Time Frame: Up to approximately 60 months ]
    the duration between the date of surgery and the date of patient death

  2. Carbohydrate antigen 19-9 [ Time Frame: Up to approximately 36 months ]
    serum Carbohydrate antigen 19-9 level

  3. Quality of Life [ Time Frame: Up to approximately 60 months ]
    assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score

  4. Common Toxicity Criteria for Adverse Effects [ Time Frame: Up to approximately 12 months ]
    according to Common Toxicity Criteria for Adverse Effects version 4



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498326


Contacts
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Contact: Tingbo Liang 13666676128 liangtingbo@zju.edu.cn
Contact: Xueli Bai shirlybai@zju.edu.cn

Locations
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China, Zhejiang
the second affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Qi Chen, MD,PhD    +8613857168284    chen_qi@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Liang Tingbo, Chairman of Department of Hepatobiliary & Pancreatic Surgery, Vice president of the Second Affiliated Hospital, Zhejiang University School of Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03498326     History of Changes
Other Study ID Numbers: SAHZhejiangU-GCRP
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University:
pancreatic cancer
gemcitabine
celecoxib
R0 resection
Additional relevant MeSH terms:
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Celecoxib
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors