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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is a type of pancreatic cancer called adenocarcinoma.
Select...
My condition is considered inoperable or nearly inoperable by a team of doctors.
Select...
I am older than 18 years.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Side effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
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%
Hypoglycemia
8%
Dysphagia-esophageal radiation
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)
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
105,022 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,622 Total Patients Enrolled
Edgar Ben-Josef, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
6 Previous Clinical Trials
188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of pancreatic cancer called adenocarcinoma.My condition is considered inoperable or nearly inoperable by a team of doctors.I am older than 18 years.I am fully active and can carry on all my pre-disease activities without restriction.My organs are working well.My cancer has spread to distant parts of my body.I have had radiation therapy to my abdomen before.I haven't had another cancer in the last 2 years, except for certain types.I have received treatment for pancreatic cancer before.I do not have any severe illnesses or mental health conditions that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment)
- Group 2: Subtrial 1-Arm A (Dose Level 1 of Abraxane)
- Group 3: Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalation
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there current opportunities for participants to join this experiment?
"The latest information on clinicaltrials.gov reveals that this investigation is recruiting participants, having initially been posted in July 2014 and edited most recently in November 2021."
Answered by AI
Has the FDA sanctioned Radiotherapy as a treatment?
"This phase 1 trial has limited evidence of safety, so it received a rating of 1."
Answered by AI
What is the maximum capacity for participants in this clinical trial?
"Affirmative. Per the information shared on clinicaltrials.gov, this medical research project is actively seeking participants; it was initially posted in July 2014 and amended last November 2021. 42 patients need to be recruited from a single site for its successful completion."
Answered by AI
Has there been any other research done on the efficacy of Radiotherapy?
"Presently, 1113 clinical trials related to Radiotherapy are ongoing. Of those experiments, 321 have progressed to the third stage and can be found in Shanghai as well as 59447 other locations around the globe."
Answered by AI
In what situations is Radiotherapy most frequently employed?
"Radiotherapy has been proven to be an effective treatment for neoplasm metastasis, locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
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