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Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

NCT01851174•Western Regional Medical Center

View on ClinicalTrials.gov

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.

Detailed Description

This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
•2. Patient has one or more radiographically measurable tumor.
•3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
•4. Age ≥ 18 years.
•5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
•6. ECOG performance status 0 - 2 and an expected survival of at least 3 months.
•7. 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
+8 more criteria

Exclusion Criteria

•1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
•2. Previous use of any chemotherapy or radiation therapy for metastatic disease.
•3. 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).
•4. Other significant active or chronic infection.
•5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
•6. Pregnant or nursing females.
•7. 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.
•8. Major surgery, other than diagnostic surgery within 4 weeks of study entry.
•9. Patient requires a legal authorized representative for consenting.

Locations (1)

Western Regional Medical Center

Goodyear, Arizona, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

February 7, 2018

Enrollment

ACTUAL participants

Conditions

Pancreatic Carcinoma Non-resectableStage IV Pancreatic Cancer

Interventions

Gemcitabine

DRUG

nab-Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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