Back to resultsPhase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Primary Purpose
Resectable Pancreatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NGC-Triple regimen
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Pancreatic Cancer focused on measuring Resectable pancreatic cancer, NGC-triple regimen
Eligibility Criteria
Major Inclusion Criteria for the Study Include the Following:
- Patient has an ECOG performance status PS 0-1. No prior chemotherapy or radiation for pancreatic cancer and no prior exposure to gemcitabine and/or nab-paclitaxel
Patient has the following blood counts at baseline:
- ANC ≥1.5 × 109/L (1500 /mm3)
- Platelets ≥100 × 109/L; (100,000/mm3)
- Hgb ≥10 g/dL
Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) ≤ 3.0 × upper limit of normal (ULN)
- Alkaline phosphatase (AP) ≤3.0 X ULN
- Total bilirubin ≤1.5 or ≤ULN
- Serum creatinine ≤1.5mg/dL or calculated clearance ≥50 mL/min/1.73 m2 for patients with serum creatinine levels >1.5 mg/dL
- Patient has acceptable coagulation status as indicated by a PT within normal limits (± 15%) and PTT within normal limits (± 15%)
Major Exclusion Criteria include the Following:
- Patient has locally advanced unresectable pancreatic cancer.
- Patients aged >75.
- Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
- Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV, hepatitis B, or hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ) within 4 weeks prior to Day 1 of treatment in this study.
- Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or nab-paclitaxel.
Patient has a history of allergy or hypersensitivity to the study drugs.
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Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resectable and borderline restable
Arm Description
Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. Patients receive 3 cycles of preoperative chemotherapy (NGC-triple regimen). The regimen consists of gemcitabine 800 mg/m2, Nab-paclitaxel 100 mg/m2and Cisplatin 25 mg/m2 given IV weekly x 2, every 3 weeks (one cycle). Patients will be evaluated for adjuvant therapy within 12 weeks of surgery which will consist of Nab-paclitaxel, gemcitabine, and Cisplatin IV weekly x 2, every 3 weeks (one cycle) x 3 cycles.
Outcomes
Primary Outcome Measures
To evaluate 2 year survival from date of entry into study
Overall survival of patients as well as 1, and 2 year survivals will be tabulated.
Secondary Outcome Measures
Determine the number and type of treatment-related adverse events as assessed by CTCAE 4.0
To determine the number and type of treatment-related adverse events as assessed by CTCAE v4.0
Histological Response to Pre-Operative Therapy
Grade III/IV histological response to preoperative therapy in resected tumor specimens
Radiological Response Rate to Pre-Operative Therapy in the Primary Tumor
Radiological response rate in the primary tumor to preoperative therapy
CA 19-9 response to preoperative therapy
CA 19-9 response to preoperative therapy
Resectability (RO and R1) Rate Following Preoperative Therapy
Resectability (RO and R1) rate following preoperative therapy in potentially operable or locally advanced patients
Determine Postoperative Complications of Surgery
Tabulate postoperative complications of surgery
Time to Recurrence
Determine Time to recurrence and patterns of recurrence within the 24 month follow-up period
Full Information
NCT ID
NCT03392571
First Posted
December 6, 2017
Last Updated
May 3, 2019
Sponsor
Pancreatic Cancer Research Team
Collaborators
Celgene
1. Study Identification
Unique Protocol Identification Number
NCT03392571
Brief Title
Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Official Title
Phase II Multi-Center Study of Nab-paclitaxel, Gemcitabine and Cisplatin (NGC-Triple Regimen as Preoperative Therapy in Patients With Potentially Resectable and Borderline Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was stopped due to lack of funding
Study Start Date
August 15, 2018 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pancreatic Cancer Research Team
Collaborators
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients.
DISEASE STATE
Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed.
Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required).
No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and are negative, then enrollment can be considered after review with the study PI).
Potentially Resectable Pancreatic Cancer
No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (SMA) and, if present, replaced right hepatic artery.
No involvement or <180° interface between tumor and vessel wall of the portal vein and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence.
For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. Borderline Resectable Pancreatic Cancer
Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible occlusion of the SMV-PV.
Tumor-vessel interface <180° of the circumference of the SMA.
Tumor-vessel interface <180° of the circumference of the celiac artery.
Reconstructible short-segment interface of any degree between tumor and hepatic artery.
Detailed Description
The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and gemcitabine given together are safe and effective. The combination of nab-paclitaxel plus gemcitabine has been studied in treating patients with pancreatic cancer, and as of September, 2013 is approved for the treatment of advanced pancreatic cancer. In this study, cisplatin will be added to nab-paclitaxel plus gemcitabine, and tested in people who have not yet had any cancer therapy for the diagnosis of localized pancreatic cancer, as treatment prior to surgery, with the goal of improving response.
Another name for nab-paclitaxel is Abraxane®. Nab-paclitaxel contains the same medication as the prescription chemotherapy drug Abraxane®. Nab-paclitaxel is approved by the FDA for the treatment of advanced breast cancer, and in September, 2013 nab-paclitaxel, combined with gemcitabine, was approved by the FDA for the treatment of advanced pancreatic cancer.
Cisplatin is approved by the FDA for the treatment of advanced bladder cancer, advanced ovarian cancer, and advanced testicular cancer and other childhood cancers. However, cisplatin is not approved by the FDA for the treatment of advanced pancreatic cancer.
Gemcitabine was approved by the FDA in 1996 for the treatment of pancreatic cancer. It is also an approved treatment for ovarian cancer, lung cancer, and breast cancer.
Nab-paclitaxel, cisplatin, and gemcitabine will be given weekly for 2 weeks followed by a week of rest, for a total of 3 cycles. A cycle is defined as one set of 3 weeks of chemotherapy treatment. Patients will undergo surgery after a minimum of 3 weeks after Cycle 3 of chemotherapy. Following surgery, patients mayl be treated for up to 3 cycles of this same chemotherapy combination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Pancreatic Cancer
Keywords
Resectable pancreatic cancer, NGC-triple regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients receive 3 cycles of preoperative chemotherapy. The regimen consists of gemcitabine 800 mg/m2, nab-paclitaxel 100 mg/m2 and cisplatin 25 mg/m2 given IV weekly x 2, every 3 weeks (one cycle).
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resectable and borderline restable
Arm Type
Experimental
Arm Description
Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed.
Patients receive 3 cycles of preoperative chemotherapy (NGC-triple regimen). The regimen consists of gemcitabine 800 mg/m2, Nab-paclitaxel 100 mg/m2and Cisplatin 25 mg/m2 given IV weekly x 2, every 3 weeks (one cycle).
Patients will be evaluated for adjuvant therapy within 12 weeks of surgery which will consist of Nab-paclitaxel, gemcitabine, and Cisplatin IV weekly x 2, every 3 weeks (one cycle) x 3 cycles.
Intervention Type
Drug
Intervention Name(s)
NGC-Triple regimen
Other Intervention Name(s)
gemcitabine, cisplatin, Nab-paclitaxel
Intervention Description
gemcitabine 800 mg/m2; Abraxane (nab-paclitaxel 100 mg/m2; cisplatin 25 mg/m2
Primary Outcome Measure Information:
Title
To evaluate 2 year survival from date of entry into study
Description
Overall survival of patients as well as 1, and 2 year survivals will be tabulated.
Time Frame
Patients will be followed for survival from Day 1 of treatment with phone calls or review of records on a monthly basis for the first 6 months, and then every 6 months for 24 months.
Secondary Outcome Measure Information:
Title
Determine the number and type of treatment-related adverse events as assessed by CTCAE 4.0
Description
To determine the number and type of treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Monitor treatment-related adverse events during neoadjuvant treatment for up to 3 months prior to surgery, and for up to 3 months after surgery.
Title
Histological Response to Pre-Operative Therapy
Description
Grade III/IV histological response to preoperative therapy in resected tumor specimens
Time Frame
Specimens obtained during surgery 3-7 weeks following last dose of chemotherapy;
Title
Radiological Response Rate to Pre-Operative Therapy in the Primary Tumor
Description
Radiological response rate in the primary tumor to preoperative therapy
Time Frame
PET/CT scans performed at Baseline, and immediately prior to surgery, 3-7 weeks following last dose of chemotherapy;
Title
CA 19-9 response to preoperative therapy
Description
CA 19-9 response to preoperative therapy
Time Frame
CA 19-9 evaluation during preoperative therapy once per treatment cycle;
Title
Resectability (RO and R1) Rate Following Preoperative Therapy
Description
Resectability (RO and R1) rate following preoperative therapy in potentially operable or locally advanced patients
Time Frame
Determine RO and R1 resectability rate at surgery, 3-7 weeks following last dose of chemotherapy;
Title
Determine Postoperative Complications of Surgery
Description
Tabulate postoperative complications of surgery
Time Frame
Evaluate surgical complications within 12 weeks post-surgery to determine eligibility for up to 3 cycles (28 days per cycle) of adjuvant treatment
Title
Time to Recurrence
Description
Determine Time to recurrence and patterns of recurrence within the 24 month follow-up period
Time Frame
After Day 1 of treatment, time to recurrence will be collected within the 24 month follow up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria for the Study Include the Following:
Patient has an ECOG performance status PS 0-1. No prior chemotherapy or radiation for pancreatic cancer and no prior exposure to gemcitabine and/or nab-paclitaxel
Patient has the following blood counts at baseline:
ANC ≥1.5 × 109/L (1500 /mm3)
Platelets ≥100 × 109/L; (100,000/mm3)
Hgb ≥10 g/dL
Patient has the following blood chemistry levels at baseline:
AST (SGOT), ALT (SGPT) ≤ 3.0 × upper limit of normal (ULN)
Alkaline phosphatase (AP) ≤3.0 X ULN
Total bilirubin ≤1.5 or ≤ULN
Serum creatinine ≤1.5mg/dL or calculated clearance ≥50 mL/min/1.73 m2 for patients with serum creatinine levels >1.5 mg/dL
Patient has acceptable coagulation status as indicated by a PT within normal limits (± 15%) and PTT within normal limits (± 15%)
Major Exclusion Criteria include the Following:
Patient has locally advanced unresectable pancreatic cancer.
Patients aged >75.
Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Patient has known infection with HIV, hepatitis B, or hepatitis C.
Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ) within 4 weeks prior to Day 1 of treatment in this study.
Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or nab-paclitaxel.
Patient has a history of allergy or hypersensitivity to the study drugs.
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12. IPD Sharing Statement
Learn more about this trial
Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
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