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Anti-metabolites

nab-paclitaxel for Pancreatic Adenocarcinoma

Phase 1

Waitlist Available

Led By Vincent J Picozzi, MD

Research Sponsored by Benaroya Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessment approximately every 8 weeks during treatment up to 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment regimen to see how well it works, and how often patients' cancer cells change from positive to negative after treatment.

Eligible Conditions

Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessment approximately every 8 weeks during treatment up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessment approximately every 8 weeks during treatment up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment approximately every 8 weeks during treatment up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of cytological conversion

Secondary outcome measures

Ability to achieve R0 (complete)

Local disease control rate.

Overall response rate

+5 more

Side effects data

From 2017 Phase 4 trial • 143 Patients • NCT02151149

56%

Anaemia

53%

Nausea

53%

Fatigue

46%

Neutropenia

43%

Peripheral sensory neuropathy

41%

Alopecia

37%

Diarrhoea

37%

Decreased appetite

29%

Vomiting

29%

Constipation

27%

Thrombocytopenia

24%

Dehydration

24%

Hypokalaemia

24%

Dyspnoea

20%

Hypomagnesaemia

20%

Dizziness

19%

Weight decreased

19%

Oedema peripheral

19%

Neutrophil count decreased

19%

Muscular weakness

19%

Hypotension

17%

Cough

16%

Peripheral motor neuropathy

16%

Leukopenia

14%

Arthralgia

14%

Dysgeusia

14%

Anxiety

14%

Epistaxis

13%

Abdominal pain

11%

Stomatitis

11%

Rash maculo-papular

11%

Pain in extremity

10%

White blood cell count decreased

10%

Fall

10%

Pyrexia

10%

Back pain

10%

Headache

Gastrooesophageal reflux disease

Platelet count decreased

Chills

Urinary tract infection

Non-cardiac chest pain

Dysphagia

Hypocalcaemia

Pneumonia

Hyperglycaemia

Dry skin

Vision blurred

Dysphonia

Hypertension

Insomnia

Blood creatinine increased

Musculoskeletal chest pain

Atrial fibrillation

Asthenia

Upper respiratory tract infection

Delirium

Pulmonary embolism

Mental status changes

Pleural effusion

Syncope

Chronic obstructive pulmonary disease

Ileus

Deep vein thrombosis

Pain

Spinal column stenosis

Seizure

Cardiac arrest

Febrile neutropenia

Small intestinal obstruction

Acute kidney injury

Cachexia

Hypoxia

Hyponatraemia

Oropharyngeal pain

Diverticulitis

Chest pain

Atrial thrombosis

Haemoptysis

Pancreatitis acute

Acute respiratory failure

Atrial flutter

Pancreatitis

Leukocytosis

Pericardial effusion

Myocardial infarction

Rectal haemorrhage

Bronchitis

Bone pain

Encephalopathy

Respiratory failure

Overdose

Contusion

100%

80%

60%

40%

20%

Study treatment Arm

Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)

Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine and Nab-PaclitaxelExperimental Treatment2 Interventions

Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Gemcitabine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Benaroya Research InstituteLead Sponsor

46 Previous Clinical Trials

12,096 Total Patients Enrolled

Vincent J Picozzi, MDPrincipal InvestigatorVirginia mason medical Center

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has nab-paclitaxel been validated by the Food and Drug Administration?

"Nab-paclitaxel was assigned a safety rating of 1 as this is an early phase trial, meaning that the efficacy and safety data are still limited."

Answered by AI

What conditions has nab-paclitaxel been shown to effectively alleviate?

"nab-paclitaxel is widely used to treat neoplasm metastasis and can also be useful in treating more localized issues like non-small cell lung cancer, as well as bladder cancers of both the urinary and metastatic variety."

Answered by AI

Are there still vacancies for participants in this experiment?

"Affirmative, the clinicaltrials.gov website reveals that this research is currently recruiting participants. The trial was first made available on May 1st 2018 and has been recently updated on July 19th 2021. 21 patients are required across one location for successful completion of the study."

Answered by AI

What is the aggregate number of participants enrolled in this clinical trial?

"Correct. Clinicaltrials.gov records state that this medical research, first posted on May 1st 2018 and last edited July 19th 2021, is now actively recruiting. 21 patients are required from a single trial location."

Answered by AI

Is there a precedent of administering nab-paclitaxel in the past?

"At this moment, 1114 studies are underway involving nab-paclitaxel with 321 of them at the Phase 3 stage. Shanghai is a major city for research into this medication, though there are 59453 centres globally running clinical trials related to it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology

2018. "Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03703089.