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Resectable Pancreatic CancerPhase 2NCT03392571

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

A Phase 2 study testing NGC-Triple regimen in people with Resectable Pancreatic Cancer, run by Pancreatic Cancer Research Team.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resectable Pancreatic Cancer
What is being tested?
NGC-Triple regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Aug 2018to 30 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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. - -

About this study

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

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

Read more
  • 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.
Read the 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.

Being tested
NGC-Triple regimen
Keywords
Resectable pancreatic cancer, NGC-triple regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NGC-Triple regimenDrug

    Also called gemcitabine, cisplatin, Nab-paclitaxel

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

Study groups in NCT03392571
Study groupRoleWhat they receive
Resectable and borderline restableExperimentalPotentially 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.
Receives: Drug: NGC-Triple regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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

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

  2. Histological Response to Pre-Operative Therapy

    Grade III/IV histological response to preoperative therapy in resected tumor specimens

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

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

    Radiological response rate in the primary tumor to preoperative therapy

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

  4. CA 19-9 response to preoperative therapy

    CA 19-9 response to preoperative therapy

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

  5. Resectability (RO and R1) Rate Following Preoperative Therapy

    Resectability (RO and R1) rate following preoperative therapy in potentially operable or locally advanced patients

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

  6. Determine Postoperative Complications of Surgery

    Tabulate postoperative complications of surgery

    Measured: Evaluate surgical complications within 12 weeks post-surgery to determine eligibility for up to 3 cycles (28 days per cycle) of adjuvant treatment

  7. Time to Recurrence

    Determine Time to recurrence and patterns of recurrence within the 24 month follow-up period

    Measured: After Day 1 of treatment, time to recurrence will be collected within the 24 month follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2018
  2. Study start15 Aug 2018 (estimated)
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Why it stopped: Study was stopped due to lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03392571
Sponsor's protocol ID
PCRT 17-001
Status last verified
May 2019
First submitted
6 Dec 2017
Last updated
7 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NGC-Triple regimen in people with Resectable Pancreatic Cancer, run by Pancreatic Cancer Research Team.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03392571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.

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