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

Head and Neck Cancer Clinical Trial

— CACTUX  

Official title:

Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (HNSCC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02270814
• Other study ID #: 201410073
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• nab-paclitaxel

• Cisplatin

• Carboplatin

Biological:
• Cetuximab

Locations

Country	Name	City	State
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Sanford Cancer Center Oncology Clinic and Pharmacy	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	OS is defined as the time from randomization to death.	Until death (estimated 24 months)
Secondary	Overall response rate	Overall response rate = complete response + partial response; Evaluated using RECIST 1.1.	8 months (estimated median length of treatment)
Secondary	Grade 3 and 4 adverse events	Adverse events will be recorded from the date of first dose of study drug (nab-paclitaxel) until 28 days after the last dose of study drug.; The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.	9 months (28 days from last dose of study drug with estimated median length of treatment of 8 months)
Secondary	Quality of life	Using the EORTC QLQ-C30, MDADI, FACT-H&N, and FACT/GOG-NTX-4.; The EORTC-QLQ-C30 has a total score, one general QOL and one "within the last week" subscale, as well as a single "overall general health" item and a single "overall QOL" item. Scale is from 1-4 with 1 = not at all and 4 = very much on 28 questions. The scale is from 1-7 on 2 questions with 1 = very poor and 7 = excellent.; The MDADI has 1 global dysphagia item, physical, function and emotional subscales and one summary scale, which is the sum of the 3 subscales rescaled to 0-100.; The FACT instruments have four subscales (physical, social, emotional and functional), as well as 11-12 head and neck cancer-specific questions. The scale goes from 1-4 with 1 = not at all and 4 = very much.	Baseline, End of cycle 2, End of cycle 6, and End of treatment (estimated median length of treatment is 8 months)
Secondary	Progression-free survival (PFS) - with maintenance therapy	PFS on maintenance therapy is defined as time from first dose of maintenance therapy to first radiologic confirmation of disease progression, or death from any cause.	8 months (estimated median length of treatment)
Secondary	Disease control	Disease control = complete response + partial response + stable disease; Evaluated using RECIST 1.1	8 months (estimated median length of treatment)

External Links

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