Back to resultsNab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
Primary Purpose
Pancreatic Neoplasm
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nab-paclitaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Written informed consent.
- Histologically or cytologically confirmed treatment-naïve metastatic or locally advanced adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
- Measurable disease as defined by RECIST (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
- Age ≥ 18 years.
- ECOG Performance Status 0 or 1.
- Adequate bone marrow function: granulocyte count ≥1500 and platelet count ≥100,000 per cubic millimeter.
Adequate liver function as defined by the following criteria:
- Total serum bilirubin <2 mg/dl.
- ALP/GGT <5 x ULN.
- Transaminases ALT/AST ≤ 2.5 x ULN.
Exclusion Criteria:
- Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permitted if it is completed > 6 months prior to the time of study enrollment.
- Inability to comply with study and/or follow-up procedures.
- Presence of significant comorbidity including clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months and any other major organ failure.
- Presence of any condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- Presence of central nervous system or brain metastases.
- Life expectancy <12 weeks.
- Pregnancy (positive pregnancy test) or lactation.
- Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy.
- Pre-existing sensory neuropathy > grade 1.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Concurrent/pre-existing use of coumadin. 14. Patients older than 76 years of age.
15. Patients with active infection. 16. Patients with chronic diarrhea.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nab-paclitaxel + Gemcitabine
Gemcitabine
Arm Description
Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.
Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).
Outcomes
Primary Outcome Measures
3-months deterioration-free rate
EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate "time until definitive deterioration" (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).
Secondary Outcome Measures
Overall Survival
Full Information
NCT ID
NCT03807999
First Posted
January 8, 2019
Last Updated
January 16, 2019
Sponsor
Hacettepe University
Collaborators
Celgene
1. Study Identification
Unique Protocol Identification Number
NCT03807999
Brief Title
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
Official Title
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Metastatic or Locally Advanced Unresectable Adenocarcinoma of The Pancreas: A Phase II Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 19, 2015 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer.
Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone
Detailed Description
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer.
Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone
Arm 1:
Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.
OR
Arm 2:
Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).
All patients will be considered for available second-line therapies or best supportive care on the discretion of the investigators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nab-paclitaxel + Gemcitabine
Arm Type
Active Comparator
Arm Description
Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.
Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
3-months deterioration-free rate
Description
EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate "time until definitive deterioration" (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).
Time Frame
From first dose of therapy to third month of therapy, 3 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From first dose to death or end of the therapy, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent.
Histologically or cytologically confirmed treatment-naïve metastatic or locally advanced adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
Measurable disease as defined by RECIST (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
Age ≥ 18 years.
ECOG Performance Status 0 or 1.
Adequate bone marrow function: granulocyte count ≥1500 and platelet count ≥100,000 per cubic millimeter.
Adequate liver function as defined by the following criteria:
Total serum bilirubin <2 mg/dl.
ALP/GGT <5 x ULN.
Transaminases ALT/AST ≤ 2.5 x ULN.
Exclusion Criteria:
Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permitted if it is completed > 6 months prior to the time of study enrollment.
Inability to comply with study and/or follow-up procedures.
Presence of significant comorbidity including clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months and any other major organ failure.
Presence of any condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
Presence of central nervous system or brain metastases.
Life expectancy <12 weeks.
Pregnancy (positive pregnancy test) or lactation.
Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Known, existing uncontrolled coagulopathy.
Pre-existing sensory neuropathy > grade 1.
Major surgery within 4 weeks of the start of study treatment, without complete recovery.
Concurrent/pre-existing use of coumadin. 14. Patients older than 76 years of age.
15. Patients with active infection. 16. Patients with chronic diarrhea.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suayib Yalcin
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32228512
Citation
Yalcin S, Dane F, Oksuzoglu B, Ozdemir NY, Isikdogan A, Ozkan M, Demirag GG, Coskun HS, Karabulut B, Evrensel T, Ustaoglu MA, Ozdemir F, Turna H, Yavuzsen T, Aykan F, Sevinc A, Akbulut H, Yuce D, Hayran M, Kilickap S. Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study. BMC Cancer. 2020 Mar 30;20(1):259. doi: 10.1186/s12885-020-06758-9.
Results Reference
derived
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Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
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