- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270814
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (CACTUX)
Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Roger Maris Cancer Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Cancer Center Oncology Clinic and Pharmacy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
Up to 6 cycles of CACTUX may be given. The CACTUX regimen consists of:
After the completion of 6 cycles of CACTUX, maintenance therapy will be given and consists of:
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Other Names:
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) - with first line therapy
Time Frame: 8 months (estimated median length of treatment)
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PFS is defined as the time from randomization to first radiologic confirmation of disease progression, or death from any cause.
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8 months (estimated median length of treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Until death (estimated 24 months)
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OS is defined as the time from randomization to death.
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Until death (estimated 24 months)
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Overall response rate
Time Frame: 8 months (estimated median length of treatment)
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Overall response rate = complete response + partial response Evaluated using RECIST 1.1. |
8 months (estimated median length of treatment)
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Grade 3 and 4 adverse events
Time Frame: 9 months (28 days from last dose of study drug with estimated median length of treatment of 8 months)
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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)
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Quality of life
Time Frame: Baseline, End of cycle 2, End of cycle 6, and End of treatment (estimated median length of treatment is 8 months)
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Using the EORTC QLQ-C30, MDADI, FACT-H&N, and FACT/GOG-NTX-4.
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Baseline, End of cycle 2, End of cycle 6, and End of treatment (estimated median length of treatment is 8 months)
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Progression-free survival (PFS) - with maintenance therapy
Time Frame: 8 months (estimated median length of treatment)
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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.
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8 months (estimated median length of treatment)
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Disease control
Time Frame: 8 months (estimated median length of treatment)
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Disease control = complete response + partial response + stable disease Evaluated using RECIST 1.1 |
8 months (estimated median length of treatment)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Douglas R Adkins, M.D., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
- Cetuximab
Other Study ID Numbers
- 201410073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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