Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

NCT02318095 | Completed Results

• 1 other identifier: Pro00058865
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Resectable Pancreatic Cancers

Keywords

Cancer of the pancreas

Outcome Measures

Primary Outcomes (1)

• 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).

  approximately 6 months

Secondary Outcomes (3)

• Number of Participants Experiencing Grade >/=2 Acute Toxicity

  60 days post surgery

• Number of Participants Who Underwent Surgical Resection

  14-30 days post surgery

• Number of Participants Who Received an R0 Resection

  14-30 days post surgery

Study Arms (1)

Chemotherapy/radiation/surgery

OTHER

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.

Drug: Gemcitabine/nab-Paclitaxel; Radiation: Radiation therapy; Other: Sugical resection; Drug: Adjuvant chemotheapy

Interventions

Gemcitabine/nab-Paclitaxel DRUG

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.

Chemotherapy/radiation/surgery

Radiation therapy RADIATION

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

Chemotherapy/radiation/surgery

Sugical resection OTHER

Surgical resection of the pancreas post radiation therapy

Chemotherapy/radiation/surgery

Adjuvant chemotheapy DRUG

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

Chemotherapy/radiation/surgery

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Linda Kaltenbach, PhD
• Organization: Regulatory Coordinator

Linda.Kaltenbach@duke.edu

(919) 681-6804

Study Officials

• Manisha Palta, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: February 17, 2015
• Primary Completion: November 7, 2018
• Study Completion: November 14, 2022
• Last Updated: October 26, 2023
• Results First Posted: July 1, 2021

Record last verified: 2023-10

Locations

US (1)