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Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

Primary Purpose

Resectable Pancreatic Cancers

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine/nab-Paclitaxel

Radiation therapy

Sugical resection

Adjuvant chemotheapy

About this trial

This is an interventional treatment trial for Resectable Pancreatic Cancers focused on measuring Cancer of the pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has signed informed consent and is willing to comply with the protocol
Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
Patient is 18 years or older
Karnofsky performance status 70 or greater
The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL
Laboratory values meet the following constraints: Bilirubin less than or equal to 2 mg/dL; AST and ALT less than or equal to 3 x ULN (stenting to improve biliary obstruction is permitted)
No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis.

Exclusion Criteria:

Metastatic disease on pretreatment imaging
Prior systemic therapy
Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI
Previous treatment for pancreatic cancer
Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
Pregnant or lactating. Adequate birth control must be used if of child bearing potential per institutional policy. Negative pregnancy test in female patients of child-bearing potential per institutional policy. Post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing
Clinically significant peripheral vascular disease
Presence of active or chronic infection
Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart Class II/III/IV CHF, ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start
History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis)
Current grade 2 or higher peripheral neuropathy
Anticoagulation with warfarin
History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months
Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months

Sites / Locations

Duke Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Chemotherapy/radiation/surgery

Arm Description

This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.

Outcomes

Primary Outcome Measures

Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen

The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 17 of the 25 patients adhere to the neoadjuvant regimen and c) the acute grade 3+ non-hematologic acute toxicity is less than 50% (exclusing fatigue and alopecia).

Secondary Outcome Measures

Number of Participants Experiencing Grade >/=2 Acute Toxicity

CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during HIGRT treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days.

Number of Participants Who Underwent Surgical Resection

Patients who undergo surgical resection will be documented

Number of Participants Who Received an R0 Resection

Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

Full Information

NCT ID

NCT02318095

First Posted

December 12, 2014

Last Updated

April 3, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02318095

Brief Title

Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

Official Title

Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 17, 2015 (Actual)

Primary Completion Date

November 7, 2018 (Actual)

Study Completion Date

November 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer

Detailed Description

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection. Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Cancers

Keywords

Cancer of the pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy/radiation/surgery

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine/nab-Paclitaxel

Intervention Description

Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Description

5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.

Intervention Type

Other

Intervention Name(s)

Sugical resection

Intervention Description

Surgical resection of the pancreas post radiation therapy

Intervention Type

Drug

Intervention Name(s)

Adjuvant chemotheapy

Intervention Description

Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist

Primary Outcome Measure Information:

Title

Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen

Description

Time Frame

approximately 6 months

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing Grade >/=2 Acute Toxicity

Description

Time Frame

60 days post surgery

Title

Number of Participants Who Underwent Surgical Resection

Description

Patients who undergo surgical resection will be documented

Time Frame

14-30 days post surgery

Title

Number of Participants Who Received an R0 Resection

Description

Time Frame

14-30 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has signed informed consent and is willing to comply with the protocol Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days) Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN]) Patient is 18 years or older Karnofsky performance status 70 or greater The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL Laboratory values meet the following constraints: Bilirubin less than or equal to 2 mg/dL; AST and ALT less than or equal to 3 x ULN (stenting to improve biliary obstruction is permitted) No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis. Exclusion Criteria: Metastatic disease on pretreatment imaging Prior systemic therapy Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI Previous treatment for pancreatic cancer Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance Pregnant or lactating. Adequate birth control must be used if of child bearing potential per institutional policy. Negative pregnancy test in female patients of child-bearing potential per institutional policy. Post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing Clinically significant peripheral vascular disease Presence of active or chronic infection Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart Class II/III/IV CHF, ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis) Current grade 2 or higher peripheral neuropathy Anticoagulation with warfarin History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manisha Palta, MD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

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