- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026905
A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan, 800
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung, Taiwan
- Recruiting
- Taichung Veterans General Hospital
-
Contact:
- YU-HSUAN SHIH, MD
- Email: rollingstone07@gmail.com
-
Principal Investigator:
- YU-HSUAN SHIH
-
Sub-Investigator:
- Kuan-Der Lee
-
Sub-Investigator:
- Huey-En Tzeng
-
Sub-Investigator:
- Youngsen Yang
-
Sub-Investigator:
- Cheng-wei Chou
-
Sub-Investigator:
- Hsin-Chen Lin
-
Taichung, Taiwan, 400
- Recruiting
- China Medical University Hospital
-
Tainan, Taiwan, 600
- Recruiting
- National Cheng Kung University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.
- B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study.
- C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated.
- D.At least one measurable lesion according to RECIST version 1.1
- E.Ability to understand and willingness to sign a written informed consent document.
- F.ECOG performance status 0-1
- G.Age of 20 years or above
- H.Adequate organ function as defined by the following criteria:
absolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥ 100,000/mm3 total bilirubin ≤ 2 ULN or ≤5 ULN if caused by biliary obstruction and achieving adequate drainage judged by investigator aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0×ULN in the presence of liver metastases creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: [(140 - age) × weight (kg)]/[72 × serum creatinine(mg/dL)];female=male x 0.85
-I.Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
Exclusion Criteria:
- A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.
- B.Active or uncontrolled infection;
- C.Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion
- D.Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
- E.History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: GASL arm
eligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day [depending on patient's baseline body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
|
Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.
Other Names:
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
Other Names:
S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
Other Names:
leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
Other Names:
|
OTHER: GAP arm
eligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle.
|
Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.
Other Names:
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
Other Names:
Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best objective response rate (ORR)
Time Frame: 6 years
|
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
|
6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: 6 years
|
Defined as having complete response, partial response or stable disease at least 12 weeks.
|
6 years
|
Progression-free survival (PFS)
Time Frame: 6 years
|
from the start date of study treatment to the date of progression disease or death.
|
6 years
|
Overall survival (OS)
Time Frame: 6 years
|
from the start date of study treatment to the date of death.
|
6 years
|
Duration of response (DOR)
Time Frame: 6 years
|
time from documentation of tumor response to disease progression.
|
6 years
|
Incidence of Treatment-related Adverse Events [Safety and Tolerability]
Time Frame: 6 years
|
This study will utilize the NCI-CTCAE v5.0 for Adverse Event monitoring and reporting
|
6 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Gemcitabine
- Paclitaxel
- Oxaliplatin
- Leucovorin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- T5221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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