Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

NCT01470417 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB201701386GAIN-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• Biochemical Response Rate

  Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.

  4 - 8 weeks after neoadjuvant therapy

• Radiographic Response Rate

  Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.

  4 - 8 weeks after neoadjuvant therapy

• Pathologic Downstaging and Margin Status

  Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.

  At the time of surgery after neoadjuvant therapy

Secondary Outcomes (1)

• 90 Day Post-operative Mortality

  90 days after surgery

Study Arms (2)

Chemotherapy

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.

Drug: Chemotherapy

Chemotherapy and ChemoRadiotherapy

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.

Drug: Chemotherapy + ChemoRadiotherapy

Interventions

Chemotherapy DRUG

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.

Also known as: Abraxane, Gemcitabine

Chemotherapy

Chemotherapy + ChemoRadiotherapy DRUG

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.

Also known as: Abraxane, Gemcitabine

Chemotherapy and ChemoRadiotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Albumin-Bound Paclitaxel; Gemcitabine; Chemoradiotherapy

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; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Radiotherapy

Results Point of Contact

• Title: Thomas J. George, Jr., MD
• Organization: University of Florida

thom.george@medicine.ufl.edu

(352) 273-8008

Study Officials

• Thomas George, MD, FACP

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: October 1, 2019
• Last Updated: August 22, 2023
• Results First Posted: February 9, 2015

Record last verified: 2020-01

Locations

US (1)