Clinical trial NCT02318095: 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
Overall status: COMPLETED
Phase: NA
Conditions: Resectable Pancreatic Cancers
Keywords: Cancer of the pancreas
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patient has signed informed consent and is willing to comply with the protocol
2. Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
3. Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network \[NCCN\])
4. Patient is 18 years or older
5. Karnofsky performance status 70 or greater
6. The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL
7. 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)
8. No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis.

Exclusion Criteria:

1. Metastatic disease on pretreatment imaging
2. Prior systemic therapy
3. Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI
4. Previous treatment for pancreatic cancer
5. Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
6. 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
7. Clinically significant peripheral vascular disease
8. Presence of active or chronic infection
9. 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
10. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start
11. History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis)
12. Current grade 2 or higher peripheral neuropathy
13. Anticoagulation with warfarin
14. History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months
15. Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months

Primary outcomes:
measure: Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen
timeFrame: approximately 6 months
Secondary outcomes:
measure: Number of Participants Experiencing Grade >/=2 Acute Toxicity
timeFrame: 60 days post surgery
measure: Number of Participants Who Underwent Surgical Resection
timeFrame: 14-30 days post surgery
measure: Number of Participants Who Received an R0 Resection
timeFrame: 14-30 days post surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Manisha Palta, MD
role: PRINCIPAL_INVESTIGATOR
References: