Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments chemotherapy, chemotherapy + chemoradiotherapy
Phase phase 2
Sponsor University of Florida
Start date October 2011
End date January 2014
Trial size 10 participants
Trial identifier NCT01470417, GAIN-1

Summary

This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
chemotherapy Abraxane
Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
(Active Comparator)
Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
chemotherapy + chemoradiotherapy Abraxane
Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.

Primary Outcomes

Measure
Biochemical Response Rate
time frame: 4 - 8 weeks after neoadjuvant therapy
Radiographic Response Rate
time frame: 4 - 8 weeks after neoadjuvant therapy
Pathologic Downstaging and Margin Status
time frame: At the time of surgery after neoadjuvant therapy

Secondary Outcomes

Measure
Disease Free Survival
time frame: 5 years
Overall Survival
time frame: 5 years after treatment
90 Day Post-operative Mortality
time frame: 90 days after surgery
Treatment Associated Toxicity
time frame: 5 years
Quality of Life Analysis
time frame: 2 years
Prognostic Risk Stratifiers
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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 (BR) - Age between 18 and 90 years at the time of consent. - Patients with biliary obstruction must have adequate drainage prior to starting treatment. - 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 ascites - 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 carbamazepine) - 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 physician

Additional Information

Official title GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
Principal investigator Thomas George, MD, FACP
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Florida.