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Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392571
Recruitment Status : Withdrawn (Study was stopped due to lack of funding)
First Posted : January 8, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Pancreatic Cancer Research Team

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE January 8, 2018
Last Update Posted Date May 7, 2019
Estimated Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
To evaluate 2 year survival from date of entry into study [ 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. ]
Overall survival of patients as well as 1, and 2 year survivals will be tabulated.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03392571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Determine the number and type of treatment-related adverse events as assessed by CTCAE 4.0 [ 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. ]
    To determine the number and type of treatment-related adverse events as assessed by CTCAE v4.0
  • Histological Response to Pre-Operative Therapy [ Time Frame: Specimens obtained during surgery 3-7 weeks following last dose of chemotherapy; ]
    Grade III/IV histological response to preoperative therapy in resected tumor specimens
  • Radiological Response Rate to Pre-Operative Therapy in the Primary Tumor [ Time Frame: PET/CT scans performed at Baseline, and immediately prior to surgery, 3-7 weeks following last dose of chemotherapy; ]
    Radiological response rate in the primary tumor to preoperative therapy
  • CA 19-9 response to preoperative therapy [ Time Frame: CA 19-9 evaluation during preoperative therapy once per treatment cycle; ]
    CA 19-9 response to preoperative therapy
  • Resectability (RO and R1) Rate Following Preoperative Therapy [ Time Frame: Determine RO and R1 resectability rate at surgery, 3-7 weeks following last dose of chemotherapy; ]
    Resectability (RO and R1) rate following preoperative therapy in potentially operable or locally advanced patients
  • Determine 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 ]
    Tabulate postoperative complications of surgery
  • Time to Recurrence [ Time Frame: After Day 1 of treatment, time to recurrence will be collected within the 24 month follow up period ]
    Determine Time to recurrence and patterns of recurrence within the 24 month follow-up period
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
  • Determine the number and type of treatment-related adverse events as assessed by CTCAE 4.0 [ 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. ]
    To determine the number and type of treatment-related adverse events as assessed by CTCAE v4.0
  • Histological Response to Pre-Operative Therapy [ Time Frame: Specimens obtained during surgery 3-7 weeks following last dose of chemotherapy; ]
    Grade III/IV histological response to preoperative therapy in resected tumor specimens
  • Radiological Response Rate to Pre-Operative Therapy in the Primary Tumor [ Time Frame: PET/CT scans performed at Baseline, and immediately prior to surgery, 3-7 weeks following last dose of chemotherapy; ]
    Radiological response rate in the primary tumor to preoperative therapy
  • CA 19-9 response to preoperative therapy [ Time Frame: CA 19-9 evaluation during preoperative therapy once per treatment cycle; ]
    CA 19-9 response to preoperative therapy
  • Resectability (RO and R1) Rate Following Preoperative Therapy [ Time Frame: Determine RO and R1 resectability rate at surgery, 3-7 weeks following last dose of chemotherapy; ]
    Resectability (RO and R1) rate following preoperative therapy in potentially operable or locally advanced patients
  • Determine 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 ]
    Tabulate postoperative complications of surgery
  • Time to Recurrence and Patterns of Recurrence [ Time Frame: After Day 1 of treatment, time to recurrence will be collected within the 24 month follow up period ]
    Determine Time to recurrence and patterns of recurrence within the 24 month follow-up period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Resectable Pancreatic Cancer
Intervention  ICMJE Drug: NGC-Triple regimen
gemcitabine 800 mg/m2; Abraxane (nab-paclitaxel 100 mg/m2; cisplatin 25 mg/m2
Other Names:
  • gemcitabine
  • cisplatin
  • Nab-paclitaxel
Study Arms  ICMJE Experimental: Resectable and borderline restable

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: Drug: NGC-Triple regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
70
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  1. Patient has locally advanced unresectable pancreatic cancer.
  2. Patients aged >75.
  3. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
  4. Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT.
  5. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  6. Patient has known infection with HIV, hepatitis B, or hepatitis C.
  7. 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.
  8. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or nab-paclitaxel.
  9. Patient has a history of allergy or hypersensitivity to the study drugs.

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03392571
Other Study ID Numbers  ICMJE PCRT 17-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pancreatic Cancer Research Team
Study Sponsor  ICMJE Pancreatic Cancer Research Team
Collaborators  ICMJE Celgene
Investigators  ICMJE Not Provided
PRS Account Pancreatic Cancer Research Team
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP