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Alkylating agents
paclitaxel albumin-stabilized nanoparticle formulation for Salivary Gland Cancer
Phase 1
Waitlist Available
Led By Jonas de Souza
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status of one or less
Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a nanoparticle formulation of paclitaxel given with carboplatin, followed by chemoradiation, to treat patients with recurrent head and neck cancer.
Who is the study for?
This trial is for patients with recurrent head and neck cancer who've completed prior radiation therapy at least 4 months ago or chemotherapy over a month ago. They should have measurable disease, be in good physical condition (ECOG performance status of one or less), expect to live more than 12 weeks, and use effective contraception if applicable. People with untreated locoregional-only disease, recent chemo within the last month, severe allergies to similar drugs, significant neuropathy, or uncontrolled illnesses can't participate.Check my eligibility
What is being tested?
The study tests how safe and effective it is to give paclitaxel albumin-stabilized nanoparticle formulation with carboplatin followed by various chemoradiation therapies for recurrent head and neck cancers. It aims to find the best dose of this combination treatment that stops tumor growth by killing cells or preventing them from dividing.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy like nausea, hair loss, fatigue; nerve damage symptoms such as tingling; blood count changes leading to increased infection risk; liver function alterations; kidney issues reflected in altered urine production; and general discomfort from radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My head or neck cancer has come back and needs treatment.
Select...
My cancer in the head or neck area has returned but hasn't spread far.
Select...
My cancer can be treated with radiation.
Select...
I do not have severe numbness or pain in my hands or feet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fluorouracil
Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0
Secondary outcome measures
Objective response rate (complete response [CR] + partial response [PR])
Overall survival
PFS
Side effects data
From 2010 Phase 2 trial • 76 Patients • NCT0040423590%
Hemoglobin decreased
90%
Fatigue
72%
Neutrophil count decreased
56%
Nausea
51%
Platelet count decreased
49%
Peripheral sensory neuropathy
33%
Myalgia
26%
Vomiting
26%
Joint pain
23%
Leukocyte count decreased
21%
Alopecia
13%
Constipation
10%
Lymphocyte count decreased
10%
Hypersensitivity
8%
Diarrhea
8%
Fever
5%
Dyspepsia
5%
Dehydration
5%
Anorexia
5%
Hyperglycemia
3%
Diplopia
3%
Creatinine increased
3%
Hearing loss
3%
Catheter related infection
3%
Colitis, infectious (e.g., Clostridium difficile)
3%
Skin infection
3%
Hypotension
3%
Abdominal distension
3%
Bladder infection
3%
Thrombosis
3%
Hemorrhage
3%
Proteinuria
3%
Back pain
3%
Neuralgia
3%
Hot flashes
3%
Urinary tract infection
3%
Edema limbs
3%
Hypocalcemia
3%
Neck pain
3%
Buttock pain
3%
Peripheral motor neuropathy
3%
Taste alteration
3%
Tumor pain
3%
Pain in extremity
3%
Headache
3%
Weight loss
3%
Ear, nose and throat examination abnormal
3%
Vaginal dryness
3%
Dyspnea
3%
Nasal congestion
3%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 (Chemotherapy Naive, CN)
Cohort 1 (Prior Chemotherapy, PT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (induction therapy and AFHX or AXX)Experimental Treatment8 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Albumin human
FDA approved
Fluorouracil
FDA approved
Hydroxyurea
FDA approved
therapeutic conventional surgery
2003
Completed Phase 3
~12270
radiation therapy
1994
Completed Phase 3
~13390
hyperfractionated radiation therapy
2006
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,802 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,619 Total Patients Enrolled
Jonas de SouzaPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished radiation therapy 4 months ago or chemotherapy 1 month ago and have recovered from side effects.My cancer can be treated with radiation.I do not have severe numbness or pain in my hands or feet.I am fully active and can carry on all pre-disease activities without restriction.I have severe nerve issues in my hands or feet that affect my daily activities.My head or neck cancer has come back and needs treatment.My cancer in the head or neck area has returned but hasn't spread far.I have been treated before for my cancer that has not spread beyond its original region.I haven't had chemotherapy in the last 4 weeks and have recovered from any past side effects.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (induction therapy and AFHX or AXX)
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.
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