Clinical Trials /

Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Platin, 5-FU, Cetuximab, and Taxane

NCT02369458

Description:

No agent is known to have efficacy in patients with incurable HNSCC that progressed with prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this trial. Based on the preclinical and clinical data presented, the investigators propose that mitomycin C will have anti-tumor activity in these patients.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Mitomycin C</span> in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative <span class="go-doc-concept go-doc-disease">Head and Neck Squamous Cell Carcinoma (HNSCC)</span> Resistant to <span class="go-doc-concept go-doc-intervention">Platin</span>, <span class="go-doc-concept go-doc-intervention">5-FU</span>, <span class="go-doc-concept go-doc-intervention">Cetuximab</span>, and <span class="go-doc-concept go-doc-intervention">Taxane</span>

Title

  • Brief Title: Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Platin, 5-FU, Cetuximab, and Taxane
  • Official Title: Phase II Trial of Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Platin, 5-FU, Cetuximab, and Taxane
  • Clinical Trial IDs

    NCT ID: NCT02369458

    ORG ID: 201503060

    Trial Conditions

    Squamous Cell Carcinoma of the Head and Neck

    Squamous Cell Carcinoma, Head and Neck

    Trial Interventions

    Drug Synonyms Arms
    Mitomycin-C Mitosol, Mitomycin Arm 1: p16+ OPSCC, Arm 2: p16- HNSCC
    Pegfilgrastim Neulasta, GCSF Arm 1: p16+ OPSCC, Arm 2: p16- HNSCC

    Trial Purpose

    No agent is known to have efficacy in patients with incurable HNSCC that progressed with
    prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this
    trial. Based on the preclinical and clinical data presented, the investigators propose that
    mitomycin C will have anti-tumor activity in these patients.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1: p16+ OPSCC Experimental Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks). Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection) Mitomycin-C, Pegfilgrastim
    Arm 2: p16- HNSCC Experimental Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks). Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection) Mitomycin-C, Pegfilgrastim

    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-cutaneous 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).

    - Progression following platin, 5-FU, cetuximab and taxane given for incurable disease.

    - 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.

    - Tissue available (either initial diagnostic or recurrent tissue specimen) for p16
    testing.

    - At least 18 years of age.

    - ECOG performance status 3

    - Adequate hematologic, renal, and hepatic function as defined below:

    - Absolute neutrophil count 1,000/mcl

    - Platelets 75,000/mcl

    - Total bilirubin 1.5 mg/dL

    - AST(SGOT)/ALT(SGPT) 2.5 x ULN, alkaline phosphatase 2.5 x ULN, unless bone
    metastasis is present in the absence of liver metastasis

    - Creatinine below ULN (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

    - 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 1 month 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:

    - Other active malignancy with the exception of basal cell or squamous cell carcinoma
    of the skin which were treated with local resection only, carcinoma in situ of the
    cervix, or synchronous H&N primaries.

    - Currently receiving any other investigational agents.

    - 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 7
    days of start of study treatment.

    - Known active central nervous system (CNS) metastases. Subjects with previously
    treated brain metastases may participate provided they are stable (without evidence
    of progression by imaging for at least four weeks prior to the first dose of trial
    treatment and any neurologic symptoms have returned to baseline), have no evidence of
    new or enlarging brain metastases, and are not using steroids for at least 28 days
    prior to treatment.

    - A history of allergic reactions attributed to compounds of similar chemical or
    biologic composition to mitomycin C or other agents used in the study.

    - 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Tumor response rate (TRR)

    Secondary Outcome Measures

    Progression-free survival (PFS)

    Grades 3 and 4 adverse events

    Overall survival (OS)

    Quality of life

    Trial Keywords