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

NCT03392571 | Withdrawn Phase 2

• 1 other identifier: PCRT 17-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Resectable Pancreatic Cancer

Keywords

Resectable pancreatic cancer, NGC-triple regimen

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (7)

• Determine the number and type of treatment-related adverse events as assessed by CTCAE 4.0

  Monitor treatment-related adverse events during neoadjuvant treatment for up to 3 months prior to surgery, and for up to 3 months after surgery.

• Histological Response to Pre-Operative Therapy

  Specimens obtained during surgery 3-7 weeks following last dose of chemotherapy;

• Radiological Response Rate to Pre-Operative Therapy in the Primary Tumor

  PET/CT scans performed at Baseline, and immediately prior to surgery, 3-7 weeks following last dose of chemotherapy;

• CA 19-9 response to preoperative therapy

  CA 19-9 evaluation during preoperative therapy once per treatment cycle;

• Resectability (RO and R1) Rate Following Preoperative Therapy

  Determine RO and R1 resectability rate at surgery, 3-7 weeks following last dose of chemotherapy;

Study Arms (1)

Resectable and borderline restable

EXPERIMENTAL

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.

Drug: NGC-Triple regimen

Interventions

NGC-Triple regimen DRUG

gemcitabine 800 mg/m2; Abraxane (nab-paclitaxel 100 mg/m2; cisplatin 25 mg/m2

Also known as: gemcitabine, cisplatin, Nab-paclitaxel

Resectable and borderline restable

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pancreatic Cancer Research Team: lead
• Celgene: collaborator

MeSH Terms

Interventions

Gemcitabine; Cisplatin; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 8, 2018
• Study Start: August 15, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-05