Clinical Trials /

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

NCT02270814

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma
  • 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 IDs

  • ORG STUDY ID: 201410073
  • NCT ID: NCT02270814

Conditions

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

Interventions

DrugSynonymsArms
nab-paclitaxelAbraxane, Albumin-bound paclitaxel, Paclitaxel protein-boundCACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
CisplatinCisplatinum, CDDP, cis-DDP, cis-Diamminedichloroplatinum, cis-Platinum II, DDPCACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
CarboplatinParaplatin®, CBDCACACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
CetuximabErbitux®CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximabExperimentalUp 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
  • nab-paclitaxel
  • Cisplatin
  • Carboplatin
  • Cetuximab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) - with first line therapy
Time Frame:8 months (estimated median length of treatment)
Safety Issue:
Description:PFS is defined as the time from randomization to first radiologic confirmation of disease progression, or death from any cause.

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Until death (estimated 24 months)
Safety Issue:
Description:OS is defined as the time from randomization to death.
Measure:Overall response rate
Time Frame:8 months (estimated median length of treatment)
Safety Issue:
Description:Overall response rate = complete response + partial response Evaluated using RECIST 1.1.
Measure: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)
Safety Issue:
Description: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.
Measure: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)
Safety Issue:
Description: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.
Measure:Progression-free survival (PFS) - with maintenance therapy
Time Frame:8 months (estimated median length of treatment)
Safety Issue:
Description: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.
Measure:Disease control
Time Frame:8 months (estimated median length of treatment)
Safety Issue:
Description:Disease control = complete response + partial response + stable disease Evaluated using RECIST 1.1

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Washington University School of Medicine

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