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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

Must not have

Known brain metastases

Known HIV-positivity on combination antiretroviral therapy

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

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to my brain.

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I am HIV positive and on antiretroviral therapy.

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I have received treatment for a disease considered incurable.

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I do not have any uncontrolled illnesses.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) - with first line therapy

Secondary study objectives

Disease control

Grade 3 and 4 adverse events

Overall response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1420

Cisplatin

2013

Completed Phase 3

~3120