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

NCT02270814 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 201410073
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer; Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

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

  PFS is defined as the time from randomization to first radiologic confirmation of disease progression, or death from any cause.

  8 months (estimated median length of treatment)

Secondary Outcomes (6)

• Overall survival (OS)

  Until death (estimated 24 months)

• Overall response rate

  8 months (estimated median length of treatment)

• Grade 3 and 4 adverse events

  9 months (28 days from last dose of study drug with estimated median length of treatment of 8 months)

• Quality of life

  Baseline, End of cycle 2, End of cycle 6, and End of treatment (estimated median length of treatment is 8 months)

• Progression-free survival (PFS) - with maintenance therapy

  8 months (estimated median length of treatment)

Study Arms (1)

CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

EXPERIMENTAL

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

Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Biological: Cetuximab

Interventions

nab-paclitaxel DRUG

Also known as: Abraxane, Albumin-bound paclitaxel, Paclitaxel protein-bound

CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

Cisplatin DRUG

Also known as: Cisplatinum, CDDP, cis-DDP, cis-Diamminedichloroplatinum, cis-Platinum II, DDP

CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

Carboplatin DRUG

Also known as: Paraplatin®, CBDCA

CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

Cetuximab BIOLOGICAL

Also known as: Erbitux®

CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Prior systemic therapy for incurable disease.
• Grade 2 or higher peripheral neuropathy at screening.
• A history of other malignancy ≤ 2 years previous; exceptions are malignancies with a negligible risk of metastasis or death (e.g., expected 5-year OS \> 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, incidental finding of prostate cancer (TNM stage of T1a or T1b), or synchronous H\&N primaries
• Currently receiving any other investigational agents.
• Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, nab-paclitaxel, or other agents used in the study. Previous grade 1 or 2 allergic reaction to cetuximab is permissible.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 72 hours of start of study treatment.
• Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celgene Corporation: collaborator

Study Sites (5)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Sanford Cancer Center Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, 57104, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Cisplatin; Carboplatin; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Douglas R Adkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: February 2, 2015
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)