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Antimetabolite

PEGPH20 + Chemotherapy for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Southwest Oncology Group
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 up to 3 years
Awards & highlights

Study Summary

This triallooks at side effects & best dose of a drug to make chemo work better for pancreatic cancer that has spread.

Eligible Conditions
  • Pancreatic Cancer Metastatic

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX
Phase II: Overall Survival
Secondary outcome measures
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)
Progression Free Survival (PFS) (Phase II)
Other outcome measures
Cancer Antigen (CA) 19-9 Levels
Plasma Expression of Hyaluronan (HA)
Tumor Expression of HA

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990
68%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Insomnia
20%
Paraesthesia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Intestinal perforation
1%
Infective exacerbation of chronic obstructive airways disease
1%
Inguinal hernia
1%
Colitis
1%
Colonic obstruction
1%
Muscle abscess
1%
Infected dermal cyst
1%
Gastrointestinal perforation
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase II: mFOLFIRINOX + PEGPH20Experimental Treatment5 Interventions
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Group II: Phase IExperimental Treatment5 Interventions
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes; Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours; Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours; Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours; 5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours
Group III: Phase II: mFOLFIRINOXActive Control4 Interventions
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEGPH20
2014
Completed Phase 2
~540
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Irinotecan
2017
Completed Phase 4
~2680
5-fluorouracil
2005
Completed Phase 4
~7960

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,685 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,044 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,027 Total Patients Enrolled

Frequently Asked Questions

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

What conditions can Leucovorin bolster amelioration for?

"Leucovorin is a widely used remedy for macrocytic anemia, but can also be employed in the treatment of rehydration, bladder cancer and malignant neoplasms."

Answered by AI

Are enrollment opportunities available for this clinical trial at present?

"According to clinicaltrials.gov, this trial is no longer actively seeking patients as the last time it was updated was on November 9th 2022. Despite that fact, there are presently 1463 other medical trials in search of participants."

Answered by AI

How many individuals have signed up to participate in this research endeavor?

"This investigation is no longer seeking new participants. Its initial posting was on January 1st 2014, and it was last modified on November 9th 2022. Although this trial has concluded recruitment, there are currently 779 trials enrolling patients with metastatic neoplasm and 684 clinical studies recruiting volunteers for Leucovorin treatments."

Answered by AI

Do I qualify to be a participant in this research project?

"This research requires 126 participants with a history of metastatic neoplasm aged 18-75. In particular, those being considered must not have had any prior treatment in the last 3 years that included oxaliplatin or irinotecan; no past chemotherapy for metastasis; and be without pre-existing abdominal radiation therapy. Additionally, they should display a Zubrod performance status between 0 to 1."

Answered by AI

How many locations are currently conducting this trial?

"This medical trial is underway at 100 sites located across the country, including Detroit, Burlington and Bend. If you choose to enroll, it is encouraged that you select the nearest location available in order to reduce travel needs."

Answered by AI

Are there any records of prior experiments involving Leucovorin?

"Presently, there are 684 ongoing investigations into Leucovorin. Of these studies, 215 have progressed to Phase 3. Most of the clinical trials take place in Guangzhou, Guangdong; however, research is being conducted at 30878 separate sites around the world."

Answered by AI

Does the eligibility criterion for this trial encompass individuals who are of age 18 or above?

"Patients aged 18 to 75 are eligible for this clinical trial. For patients outside of that age range, there are 87 trials tailored towards minors and 1400 studies catered to seniors."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Palo Alto Medical Foundation-Sunnyvale
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
2014. "S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01959139.
~11 spots leftby Apr 2025
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