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Alkylating agents

Combination Chemotherapy for Pancreatic Cancer

N/A
Waitlist Available
Led By Kenneth Yu, MD, MSc
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status ≥70%
Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing PEGPH20 to see if it can help treat pancreatic cancer by breaking down a substance that contributes to tumor growth.

Who is the study for?
This trial is for adults with advanced pancreatic adenocarcinoma who haven't had certain treatments. They must be in good physical condition, not pregnant or breastfeeding, and willing to use effective contraception. People with serious heart disease, recent strokes, other cancers within 3 years (except some skin cancers and cervical carcinoma), or those at high risk of bleeding can't join.Check my eligibility
What is being tested?
The study tests PEGPH20's effects on pancreatic cancer by breaking down hyaluronan in tumors. It's given alongside Gemcitabine and Nab-paclitaxel—common chemotherapy drugs—to see if it helps shrink the cancer more effectively than standard treatment alone.See study design
What are the potential side effects?
PEGPH20 may cause side effects like allergic reactions due to its enzyme nature. Common chemo side effects include nausea, fatigue, hair loss, increased infection risk due to low blood counts, and potential bleeding issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform normal activities.
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My pancreatic cancer is at an advanced stage and cannot be surgically removed.
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I am 18 years old or older.
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My kidney function is normal or only slightly impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
rate of symptomatic TE events

Side effects data

From 2015 Phase 1 & 2 trial • 28 Patients • NCT01453153
60%
Muscle spasms
55%
Fatigue
55%
Oedema peripheral
50%
Myalgia
45%
Thrombocytopenia
40%
Anaemia
40%
Nausea
40%
Decreased appetite
30%
Diarrhoea
30%
Asthenia
30%
Arthralgia
25%
Insomnia
25%
Vomiting
20%
Hypoalbuminaemia
20%
Pain in extremity
15%
Vision blurred
15%
Abdominal pain upper
15%
Hyponatraemia
15%
Dizziness
15%
Depression
15%
Productive cough
15%
Dyspnoea
15%
Pulmonary embolism
15%
Hypotension
15%
Hypokalaemia
15%
Dysphonia
10%
Dyspnoea exertional
10%
Anxiety
10%
Disease progression
10%
Tachycardia
10%
Leukopenia
10%
Dry mouth
10%
Constipation
10%
Fall
10%
Aspartate aminotransferase increased
10%
Blood alkaline phosphatase increased
10%
Dehydration
10%
Back pain
10%
Dysgeusia
10%
Flushing
10%
Neutrophil count decreased
10%
Eructation
10%
Hyperbilirubinaemia
10%
Alanine aminotransferase increased
10%
Weight decreased
10%
Hypomagnesaemia
10%
Musculoskeletal pain
10%
Night sweats
5%
Tinnitus
5%
Fluid retention
5%
Candidiasis
5%
Gastrointestinal sounds abnormal
5%
Malaise
5%
Rectal haemorrhage
5%
Cancer pain
5%
Hyperglycaemia
5%
Sinus tachycardia
5%
Lymphopenia
5%
Abdominal pain
5%
Cerebrovascular accident
5%
Bile duct obstruction
5%
Diplopia
5%
Eyelid pain
5%
Thrombocytosis
5%
Pericarditis
5%
Bradycardia
5%
Mental status changes
5%
Vertigo
5%
Infusion related reaction
5%
Blood bilirubin increased
5%
Pneumonitis
5%
Abdominal distension
5%
Abdominal pain lower
5%
Dysphagia
5%
Stomatitis
5%
Dyspepsia
5%
Gastritis
5%
Tongue discolouration
5%
Application site rash
5%
Flatulence
5%
Lip oedema
5%
Procedural pain
5%
Oral pain
5%
Sensitivity of teeth
5%
Catheter site erythema
5%
Injection site extravasation
5%
Retching
5%
Mucosal inflammation
5%
Fungal infection
5%
Oral candidiasis
5%
Spinal compression fracture
5%
Hypoglycaemia
5%
Hypocalcaemia
5%
Hypoaesthesia
5%
Pain in jaw
5%
Headache
5%
Basal ganglia infarction
5%
Cognitive disorder
5%
Tremor
5%
Presyncope
5%
Urinary hesitation
5%
Epistaxis
5%
Hiccups
5%
Pleural effusion
5%
Rash pruritic
5%
Erythema
5%
Skin ulcer
5%
Hypertension
5%
Lymphoedema
5%
Sinus congestion
5%
Hyperhidrosis
5%
Pyrexia
5%
Alopecia
5%
Neuropathy peripheral
5%
Duodenal obstruction
5%
Pancreatitis
5%
Hepatic failure
5%
Pneumonia
5%
Neutropenia
5%
Abdominal tenderness
5%
Lip pain
5%
Mouth ulceration
5%
Chest discomfort
5%
Early satiety
5%
Bile duct stenosis
5%
Contrast media reaction
5%
Excoriation
5%
Respiratory rate increased
5%
Weight increased
5%
Muscular weakness
5%
Musculoskeletal discomfort
5%
Anger
5%
Renal failure acute
5%
Urinary incontinence
5%
Erectile dysfunction
5%
Scrotal oedema
5%
Petechiae
5%
Pruritus
5%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEGPH20 3.0 μg/kg
PEGPH20 1.0 μg/kg
PEGPH20 1.6 μg/kg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients without a prior thromboembolic event (TE)Experimental Treatment3 Interventions
Patients without a prior TE will be treated with prophylactic dose and schedule of rivaroxaban (10 mg QD), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.
Group II: Patients with a prior thromboembolic event (TE)Experimental Treatment3 Interventions
Patients with a prior TE will be treated with therapeutic dose and schedule of rivaroxaban (15 mg BID for 21 days for induction if indicated, then 20 mg QD for chronic treatment), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
PEGPH20
2014
Completed Phase 2
~540

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,772 Total Patients Enrolled
Halozyme TherapeuticsIndustry Sponsor
45 Previous Clinical Trials
3,234 Total Patients Enrolled
Miami Cancer InstituteOTHER
5 Previous Clinical Trials
835 Total Patients Enrolled

Frequently Asked Questions

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

Are participants still being sought to join this trial?

"The clinical trial's records, as hosted on clinicialtrials.gov, confirm that it is not recruiting patients at the moment; however, 2215 other trials are actively looking for participants. This particular study was initially posted in October of 2016 and modified most recently in July 2022."

Answered by AI

Has research been conducted on PEGPH20 in the past?

"Currently, 1117 clinical trials related to PEGPH20 are ongoing worldwide. Of these studies, 322 have reached Phase 3 and there exist 59731 locations that host such research. The majority of the sites hosting this trial are located in Shanghai."

Answered by AI

Could you provide an estimate of the number of participants in this trial?

"Unfortunately, this research project is not currently recruiting volunteers. It was originally posted on October 1st 2016 and the most recent update took place on July 15th 2022. For those seeking alternative trials, there are 1098 studies that are accepting patients with advanced pancreatic ductal adenocarcinoma and 1117 for PEGPH20."

Answered by AI

What diseases does PEGPH20 typically help alleviate?

"PEGPH20 is most commonly used to address metastatic neoplasms, but can also be employed in various other scenarios such as the treatment of advanced non-small cell lung cancer and bladder cancers."

Answered by AI

How many medical institutions are hosting this clinical experiment?

"This medical trial is accessible at 10 different locations. Memorial Sloan Kettering Bergen in Montvale, Memorial Sloan Kettering Nassau in Uniondale and Memoral Sloan Kettering Basking Ridge in Basking Ridge are some of the sites that participants can access this study from."

Answered by AI

Who else is applying?

What site did they apply to?
Miami Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
2016. "Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02921022.
All > Adenocarcinoma
~5 spots leftby Oct 2024
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