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Platinum-based Chemotherapy

CACTUX for Head and Neck Cancer (CACTUX Trial)

Phase 2
Waitlist Available
Led By Douglas R Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 1
Histologically or cytologically confirmed incurable HNSCC of specified areas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of cycle 2, end of cycle 6, and end of treatment (estimated median length of treatment is 8 months)
Awards & highlights

CACTUX Trial Summary

This trial is testing a new cancer treatment called CACTUX. It's a combination of 3 drugs, and the investigators want to see if it's effective and has fewer side effects than the standard treatment.

Who is the study for?
Adults with incurable head and neck squamous cell carcinoma (HNSCC) that's metastatic or unresectable in a previously irradiated area. They must have measurable disease, be at least 4 months post-curative therapy if applicable, and have good organ function. Participants need to agree to contraception use during the study and for 3 months after. Exclusions include allergies to trial drugs, prior systemic therapy for incurable disease, pregnancy/breastfeeding, certain other cancers within 2 years, brain metastases, uncontrolled illnesses or HIV on antiretroviral therapy.Check my eligibility
What is being tested?
The CACTUX regimen is being tested which includes cisplatin (or carboplatin), nab-paclitaxel, and cetuximab. This combination aims to treat head and neck cancer differently from standard care by substituting nab-paclitaxel for the usual drug 5FU. The trial will assess side effects as well as how well the cancer responds and overall health status of participants.See study design
What are the potential side effects?
Possible side effects may include allergic reactions similar to those caused by compounds related to the study drugs; nerve damage symptoms like numbness or tingling; fatigue; issues affecting blood cells leading to increased infection risk; liver problems indicated by changes in specific blood tests; kidney function impairment.

CACTUX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer in the head or neck area is confirmed and cannot be cured.
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I am 18 years old or older.

CACTUX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of cycle 2, end of cycle 6, and end of treatment (estimated median length of treatment is 8 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of cycle 2, end of cycle 6, and end of treatment (estimated median length of treatment is 8 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) - with first line therapy
Secondary outcome measures
Disease control
Grade 3 and 4 adverse events
Overall response rate
+3 more

CACTUX Trial Design

1Treatment groups
Experimental Treatment
Group I: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximabExperimental Treatment4 Interventions
Up to 6 cycles of CACTUX may be given. The CACTUX regimen consists of: nab-paclitaxel given intravenously over 30 minutes on an outpatient basis on Days 1, 8, and 15 of each 21-day cycle followed by cisplatin given intravenously over 60 minutes on an outpatient basis OR carboplatin AUC5 given intravenously over 30 minutes on an outpatient basis on Day 1 of each 21-day cycle followed by cetuximab given intravenously on an outpatient basis of Days 1, 8, and 15 of each 21-day cycle Cisplatin or carboplatin may be given at the discretion of the investigator. After the completion of 6 cycles of CACTUX, maintenance therapy will be given and consists of: nab-paclitaxel given intravenously over 30 minutes on an outpatient basis on Days 1 and 8 of each 21-day cycle cetuximab given intravenously on an outpatient basis on Days 1, 8, and 15 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-paclitaxel
2008
Completed Phase 4
~1330
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,631 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,163 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
260 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02270814 — Phase 2
Head and Neck Cancers Research Study Groups: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02270814 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02270814 — Phase 2
~4 spots leftby Dec 2024
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