CACTUX for Head and Neck Cancer

(CACTUX Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Douglas R Adkins, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of cisplatin if participants have previously had problems receiving cisplatin). The use of nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU is often given instead, but the investigators group has conducted previous research where the investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and cetuximab. The investigators are looking at the incidence of side effects with the CACTUX regimen as well as response of the disease and health status.

Research Team

Douglas R Adkins, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Availability of diagnostic tumor tissue specimens for correlative studies

Ability to understand and sign an IRB approved informed consent document

My blood, kidney, and liver functions are all within normal ranges.

Exclusion Criteria

I have had cancer other than my current one in the last 2 years, with some exceptions.

I have cancer that has spread to my brain.

I am HIV positive and on antiretroviral therapy.

Treatment Details

Interventions

• Carboplatin (Platinum-based Chemotherapy)
• Cetuximab (Monoclonal Antibodies)
• Cisplatin (Platinum-based Chemotherapy)
• Nab-paclitaxel (Taxane)

Trial Overview 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.

Participant Groups

Group I: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab Experimental Treatment 4 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

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University