Active — Not RecruitingPhase 2

Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma

United States74 participantsStarted 2015-02-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically confirmed incurable HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, and/or Level 1-3 neck node with non-skin SCC and unknown primary. "Incurable" is defined as metastatic disease or a local or regional recurrence in a previously irradiated site that is unresectable (or patient declines resection). * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 1 * Adequate hematologic, renal, and hepatic function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcl * Platelets ≥ 100,000/mcl * Total bilirubin ≤ 1.5 mg/dL * AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN, alkaline phosphatase ≤ 2.5 x IULN, unless bone metastasis is present in the absence of liver metastasis * Creatinine at or below IULN (males 0.7-1.30 mg/dl; females 0.6-1.10 mg/dl) OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * At least 4 months since completion of curative therapy, if given previously. * Availability of diagnostic tumor tissue specimens for correlative studies. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 8 months (estimated median length of treatment)

Trial details

NCT IDNCT02270814

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

View on ClinicalTrials.gov More Head and Neck Cancer trials