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Taxane

Radiotherapy + Abraxane for Pancreatic Cancer

Phase 1
Recruiting
Led By Edgar Ben-Josef, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed adenocarcinoma of the pancreas
Unresectable or borderline resectable disease assessed by a multidisciplinary panel
Must not have
Distant metastatic disease
Prior history of abdominal radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new way to give chemotherapy and radiation to people with pancreatic cancer that might improve survival.

Who is the study for?
This trial is for adults over 18 with a specific type of pancreatic cancer that can't be removed by surgery or is borderline removable. They should be relatively healthy, able to consent, and willing to use birth control if they can have children. People with spread-out cancer, previous abdominal radiation, other recent cancers, or who are pregnant/nursing cannot join.
What is being tested?
The study tests increasing doses of nab-paclitaxel (Abraxane) combined with constant-dose radiation therapy in one part and then combines the best dose found with higher-dose radiation in another part. It aims to see if this combo improves survival and tumor control.
What are the potential side effects?
Potential side effects include those from radiotherapy like skin irritation and fatigue as well as those from Abraxane such as hair loss, nausea, numbness in fingers/toes, muscle pain, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of pancreatic cancer called adenocarcinoma.
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My condition is considered inoperable or nearly inoperable by a team of doctors.
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I am older than 18 years.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body.
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I have had radiation therapy to my abdomen before.
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I have received treatment for pancreatic cancer before.
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I do not have any severe illnesses or mental health conditions that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalationExperimental Treatment2 Interventions
Group II: Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment)Experimental Treatment2 Interventions
Determine the maximum dose of Abraxane that is allowable and safe for patients receiving both Abraxane and radiation therapy.
Group III: Subtrial 1-Arm A (Dose Level 1 of Abraxane)Experimental Treatment2 Interventions
Determine if it is safe or not (via occurrence of dose limiting toxicities) for patients to receive both Abraxane and radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,462 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
415 Previous Clinical Trials
464,664 Total Patients Enrolled
Edgar Ben-Josef, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
6 Previous Clinical Trials
188 Total Patients Enrolled

Media Library

nab-paclitaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT02207465 — Phase 1
Pancreatic Cancer Research Study Groups: Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment), Subtrial 1-Arm A (Dose Level 1 of Abraxane), Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalation
Pancreatic Cancer Clinical Trial 2023: nab-paclitaxel Highlights & Side Effects. Trial Name: NCT02207465 — Phase 1
nab-paclitaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02207465 — Phase 1
~4 spots leftby Dec 2025
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