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Platinum-based Chemotherapy

Chemotherapy + Immunotherapy Before Surgery for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Jared Weiss, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All males and females of childbearing potential must agree to use adequate contraception during the study
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a chemotherapy regimen to see if it can effectively treat squamous cell carcinoma of the head and neck while also reducing side effects.

Who is the study for?
This trial is for adults with a type of cancer called squamous cell carcinoma of the head and neck, which hasn't spread beyond its original location and can be surgically removed. Participants must have good performance status, measurable disease, proper bone marrow function, and adequate liver and kidney function. They should not have had major surgery recently or suffer from active serious infections or certain autoimmune diseases.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs (carboplatin and nab-paclitaxel) with an immunotherapy drug (durvalumab), before surgical removal of the tumor. The goal is to shrink tumors without radiation therapy's side effects, hoping to improve cure rates and long-term quality of life related to speech and swallowing.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from the drugs being administered into the bloodstream, fatigue, blood disorders like low counts that increase infection risk, as well as potential liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control during the study.
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I am fully active or can carry out light work.
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My liver and kidney functions are within normal ranges.
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I have a type of throat cancer that has not spread and can be removed by surgery.
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I am 18 years old or older.
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I am willing and able to follow the study's treatment and visit schedule.
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My blood tests show normal white blood cells, hemoglobin, and platelets.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection
Secondary outcome measures
Clinical Complete Response Rate and (cCRR) and Clinical Response Rate (cRR) Following Induction Chemotherapy
Overall Survival (OS) Associated With 3 Part Therapy Consisting of Induction Chemotherapy, Surgery and Risk-adapted Use of Chemoradiation
Percent of Patients Who Have a Change in Estimated Risk Level
+2 more
Other outcome measures
Cellular Correlates of Response and Changes in the Tumor Microenvironment Across Therapy
Correlation Between Measures of Clinical Response to Induction Chemotherapy and Long Term Outcomes (PFS and OS) and Compare Them to Pathologic Measures of Response (pCRR).

Trial Design

3Treatment groups
Experimental Treatment
Group I: Medium RiskExperimental Treatment6 Interventions
Part 1- Patients receive 6 weeks of induction chemotherapy comprised of weekly cycles of carboplatin dosed to an Area Under the Curve (AUC2) and nab-paclitaxel 100 mg/m2 X 6 cycles in combination with durvalumab 750 mg administered once every two weeks for 5 cycles (D1 of weeks 1, 3, 5, 7, and 9). Part 2- Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Part 3- patients receive ipsilateral involved field radiation concurrent with weekly cisplatin 30mg/m2. Once chemoradiotherapy is complete these patients will receive durvalumab 750 mg every two weeks for 3 cycles.
Group II: Low RiskExperimental Treatment4 Interventions
Part 1- Patients receive 6 weeks of induction chemotherapy comprised of weekly cycles of carboplatin dosed to an Area Under the Curve (AUC2) and nab-paclitaxel 100 mg/m2 X 6 cycles in combination with durvalumab 750 mg administered once every two weeks for 5 cycles (D1 of weeks 1, 3, 5, 7, and 9). Part 2- Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Part 3- patients receive adjuvant durvalumab (750 mg) once every two weeks x 3 cycles
Group III: High RiskExperimental Treatment6 Interventions
Part 1- Patients receive 6 weeks of induction chemotherapy comprised of weekly cycles of carboplatin dosed to an Area Under the Curve (AUC2) and nab-paclitaxel 100 mg/m2 X 6 cycles in combination with durvalumab 750 mg administered once every two weeks for 5 cycles (D1 of weeks 1, 3, 5, 7, and 9). Part 2- Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Part 3- All patients will be treated with intensity modulation radiation therapy (IMRT) concurrent with weekly cisplatin 30mg/m2 or other standard of care chemoradiotherapy regimen.Once chemoradiotherapy is complete these patients will receive durvalumab 750 mg every two weeks for 3 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Durvalumab
2017
Completed Phase 2
~3870
Carboplatin
2014
Completed Phase 3
~6670
Nab-paclitaxel
2014
Completed Phase 3
~2030
Surgical resection
2021
Completed Phase 2
~920
IMRT
2003
Completed Phase 3
~1570

Find a Location

Who is running the clinical trial?

CelgeneIndustry Sponsor
633 Previous Clinical Trials
127,913 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,205 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,241 Previous Clinical Trials
288,522,101 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03174275 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Low Risk, Medium Risk, High Risk
Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03174275 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03174275 — Phase 2

Frequently Asked Questions

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

What other types of surgeries have been explored in clinical trials?

"Surgical resection was first explored in 1997 at the City of Hope Comprehensive Cancer Centre. As of now, 2394 trials have been concluded while 1769 are currently underway; many of these studies taking place in Nashville, Tennessee."

Answered by AI

Are any openings still available for potential participants in this clinical experiment?

"This trial is currently not accepting patient applications. It was initial launched in December of 2017 and last updated at the end May 2021. Alternatively, there are 2,923 clinical trials focusing on laryngeal cancer that are open for recruitment and 1,769 active studies pertaining to Surgical resection recruiting participants."

Answered by AI

What is the scope of involvement for this research protocol?

"Unfortunately, this trial is not presently seeking new patients. Initially posted on December 19th 2017 and last updated on May 26th 2022, interested participants should consider the 2923 clinical trials actively recruiting laryngeal cancer sufferers or 1769 studies for surgical resection instead."

Answered by AI

To what types of ailments is Surgical resection typically applied?

"Surgical resection is commonly used to manage advanced non small cell lung cancer (nsclc) as well as recurrent, advance directives and other forms of soft tissue sarcoma (sts)."

Answered by AI

Has the FDA declared its approval of Surgical resection?

"Our team at Power deemed the safety of surgical resection to be a 2 because no efficacy data exists yet. However, there is preliminary evidence suggesting it is safe for use in this medical trial."

Answered by AI
~5 spots leftby Mar 2025