Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

NCT01851174 | Terminated Phase 2 Results

• 1 other identifier: WRMC 12-25
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Conditions

Pancreatic Carcinoma Non-resectable; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival Based on Toxicity Profile of Adverse Events.

  Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel

  One year

Secondary Outcomes (1)

• Progression Free Survival Time

  One year

Study Arms (1)

Gemcitabine and nab-Paclitaxel

EXPERIMENTAL

Gemcitabine (1,000 mg/m\^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m\^2) administered intravenously on days 1 and 15, every 28 days

Drug: Gemcitabine; Drug: nab-Paclitaxel

Interventions

Gemcitabine DRUG

Patients will receive Gemcitabine (1,000 mg/m\^2) IV over 30 minutes after nab-paclitaxel infusion

Also known as: Gemzar

Gemcitabine and nab-Paclitaxel

nab-Paclitaxel DRUG

Patients will receive nab-Paclitaxel (125 mg/m\^2) IV over 30 minutes before Gemcitabine infusion

Also known as: Abraxane

Gemcitabine and nab-Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
• Patient has one or more radiographically measurable tumor.
• Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
• Age ≥ 18 years.
• Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
• ECOG performance status 0 - 2 and an expected survival of at least 3 months.
• Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Hemoglobin (Hgb) ≥ 9g/dl
• Patients with adequate organ function as measured by:
• A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
• B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.
• C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.
• Women must meet one of the following criteria:

You may not qualify if:

• Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
• Previous use of any chemotherapy or radiation therapy for metastatic disease.
• Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
• Other significant active or chronic infection.
• History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
• Pregnant or nursing females.
• Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
• Major surgery, other than diagnostic surgery within 4 weeks of study entry.
• Patient requires a legal authorized representative for consenting.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jessica L. Coats
• Organization: CTCA

jessica.coats@ctca-hope.com

6232073899

Study Officials

• Madappa Kundranda, MD, PhD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: May 10, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 7, 2018
• Results First Posted: December 4, 2017

Record last verified: 2018-01

Locations

US (1)