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GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

Phase 2
18 Years
90 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

This current study proposes to conduct a prospective non-randomized open-label phase II
trial using Gemcitabine and Abraxane in the neoadjuvant treatment of resectable and
borderline-resectable pancreatic cancer. For patients that are low-risk resectable (based on
prediction rule) the plan is to administer 2 cycles of Gemcitabine and Abraxane followed by
additional systemic therapy or chemotherapy with radiation therapy (chemoRT), followed by
surgical resection. For patients who are either borderline-resectable or high-risk
resectable (see schema), the plan is to administer 2 cycles of Gemcitabine and Abraxane
followed by chemoradiotherapy concurrent with gemcitabine followed by surgical resection.
For those without high-risk features, systemic chemotherapy alone will be administered. The
primary endpoints will be R0 surgical resection rate, biochemical (CA 19-9), pathologic and
radiologic response rates. Secondary endpoints will include progression-free survival
(PFS), overall survival (OS), 30-day post-op mortality, toxicity, quality of life, pain
control, and correlative molecular exploratory analysis involving pancreatic tumor and
stromal SPARC expression levels. The investigators will also assess the patient, tumor, and
clinical characteristics that may predict R0 resectability, thus further refining the
predictive rule in high-risk patients as defined by Bao and colleagues. The investigators'
hypothesis is that by using targeted and risk-adapted chemotherapy or chemoRT, improved R0
surgical resections can be achieved and effective systemic therapy delivered, which will
translate to a significant improvement in overall survival in patients with pancreatic
adenocarcinoma, compared to published historical controls.

Inclusion Criteria:

- • Histologically or cytologically confirmed adenocarcinoma of the pancreas.

- Patients must have locally advanced pancreatic cancer, classified as either
low-risk resectable (LR), high-risk resectable (HR) or borderline resectable

- Age between 18 and 90 years at the time of consent.

- Patients with biliary obstruction must have adequate drainage prior to starting

- Patients must have ≤ Grade I peripheral neuropathy (CTCAE v 4.0)

- Patients must have ≤ ECOG Performance status 2

- Pretreatment laboratory parameters:

- Absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3

- Platelet count ≥ 100,000/mm3

- Bilirubin < 2 mg/dl

- ALT/SGPT < 10x upper limit of normal

- Creatinine < 3 mg/dl

- Calculated creatinine clearance (via Cockcroft-Gault) > 30 mL/min

- Baseline CA 19-9 levels

- Signed study specific, IRB stamped informed consent

Exclusion Criteria:

- • Evidence of any distant metastasis including peritoneal seeding and/or malignant

- Previous irradiation to the abdomen that would compromise the ability to deliver
the prescribed treatment

- Prior treatment for pancreatic cancer

- Active, untreated infection

- Surgical resection of the tumor (not including biopsies)

- Other malignancy (except non-melanoma skin cancer) that has not been
disease-free for at least 5 years.

- Pregnant and/or breast-feeding women, or patients (men and women) of
child-producing potential not willing to use medically acceptable contraception
while on treatment and for at least 3 months thereafter.

- Use of anti-epileptics (drugs such as phenytoin, phenobarbitol and

- ECG abnormality with the following: QTC >500, left bundle branch block or any
other clinically significant finding that would interfere with protocol therapy.

- History of any other disease, metabolic dysfunction, physical examination
finding, or clinical laboratory finding giving reasonable suspicion of a disease
or condition that contraindicates the use of protocol therapy or that might
affect the interpretation of the results of the study or that puts the subject
at high risk for treatment complications, in the opinion of the treating

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical response rate

Outcome Description:

Biochemical response rate (serum CA 19-9)

Outcome Time Frame:

4 - 8 weeks after neoadjuvant therapy

Safety Issue:


Principal Investigator

Thomas George, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

October 2018

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



University of Florida Shands Cancer Center Gainesville, Florida  32610-0232