Clinical Trials /

Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN

NCT02124707

Description:

This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Weekly <span class="go-doc-concept go-doc-intervention">Carboplatin</span>, <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> and <span class="go-doc-concept go-doc-intervention">Cetuximab</span> Treatment for Patients With Recurrent or Metastatic SCCHN

Title

  • Brief Title: Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
  • Official Title: LCCC 1330 - A Phase II Study of Weekly Carboplatin, Paclitaxel and Cetuximab for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Clinical Trial IDs

    NCT ID: NCT02124707

    ORG ID: LCCC 1330

    Trial Conditions

    Head and Neck Cancer

    Squamous Cell Carcinoma of the Head and Neck

    Trial Interventions

    Drug Synonyms Arms
    Cetuximab Erbitux Carboplatin, Paclitaxel and Cetuximab
    Paclitaxel Taxol Carboplatin, Paclitaxel and Cetuximab
    Carboplatin Paraplatin Carboplatin, Paclitaxel and Cetuximab

    Trial Purpose

    This is a non-randomized, open-label phase II trial of 38 patients with recurrent or
    metastatic SCCHN. Patients must have ECOG performance status of 0-1 with good organ function
    and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab.
    Following assessment of response, the treating physician at their discretion may continue to
    treat with weekly cetuximab as maintenance until disease progression. The study is designed
    to evaluate whether this regimen improves median overall survival (OS) as compared to an
    historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is
    currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen
    options are highly toxic, inconvenient and resource intensive. Our study regimen has been
    used extensively for induction therapy and off-protocol in palliative care, but treatment
    outcomes have yet to be defined by a clinical trial.

    Detailed Description

    Because of their high response rates and low toxicity, the taxane, carboplatin, cetuximab
    regimens have frequently been adapted for use in the palliative setting. At UNC, we have
    observed high rates of response, leading to symptomatic benefit and low toxicity. Further,
    the regimen de-medicalizes the patient's life in several important ways. First, unlike with
    the EXTREME regimen, no PORT or 4 day infusion is required. Second, the regimen gives only
    six weeks of cytotoxic therapy. Finally, in our experience there is a low rate of severe
    toxicity and this, coupled with the high rate of response, may improve quality of life. We
    are not aware of any presented or published results on the use of this combination in
    palliative therapy; with the adoption of this regimen in clinical practice, documentation of
    its benefit via conduct of a clinical trial is needed.

    We propose a study designed to detect an improvement in median OS versus a historical
    control. The control arm from the EXTREME trial achieved a median OS of 7.4 months. We
    hypothesize that a less toxic and more effective 3-drug regimen will result in improved
    median OS compared with the control arm from EXTREME (median 7.4 months). The toxicity
    associated with EXTREME is primarily attributable to the cisplatin and 5FU cytotoxic
    backbone as its toxicity has been consistent in multiple studies of both palliative therapy
    and induction therapy. If a 4-month improvement in OS is achieved with acceptable toxicity,
    we will consider this regimen worth of further study.

    Secondary objectives will include characterizing changes in quality of life (QoL), symptoms
    and toxicities. Patients will be encouraged to co-enroll into the UNCseq protocol for
    further exploration of associations between genetic changes and clinical outcomes.

    Trial Arms

    Name Type Description Interventions
    Carboplatin, Paclitaxel and Cetuximab Experimental A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase. Cetuximab, Paclitaxel, Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Age 18 years old

    - Histologically or cytologically confirmed recurrent or metastatic Squamous Cell
    Carcinoma of the Head and Neck (SCCHN). All primary sites are eligible excluding WHO
    type III or EBV nasopharyngeal (WHO type I and WHO type II allowed as long as they
    are EBV negative)

    - ECOG performance status 0-1

    - Adequate organ and marrow function as defined below. Laboratory tests should be
    completed within 14 days prior to registration: ANC greater than or equal to
    1,500/mm3, Platelets greater than or equal to 100,000/mm3, HgB greater than 9g/dL
    (acceptable to reach this by transfusion), Total bilirubin less than or equal to
    1.5mg/dL, Albumin greater than 2.5 g/dL, AST(SGOT)/ALT(SGPT) less than or equal to
    2.5X institutional upper limit of normal, alkaline phosphatase less than or equal to
    2.5 x upper limit of normal, GFR greater than 30 mL/min (by standard Cockroft and
    Gault formula or measured via 24 hour urine collection)

    - Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test
    within 7 days of D1 of treatment

    - WOCBP and men must agree to use adequate contraception prior to study entry and for
    duration of treatment under this protocol; adequate contraception is defined as any
    medically recommended method (or combination of methods) per standard of care.

    - Cancer must be considered incurable by the treating clinician

    - Ability to understand and willingness to sign a written informed consent document

    Exclusion Criteria:

    - History of prior cumulative exposure to > 300mg/m2 cisplatin, AUC of 18 of
    carboplatin, or their combined equivalent within one year prior to enrollment

    - Surgery or radiation within the four weeks prior to D1 of treatment under this
    protocol

    - Prior systemic chemotherapy unless it was part of definitive-intent (curative intent)
    treatment more than 6 months before study entry

    - Other active, invasive malignancy requiring ongoing therapy or expected to require
    systemic therapy within two years; localized squamous cell carcinoma of the skin,
    basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other
    malignancies requiring locally ablative therapy only will not result in exclusion

    - Pregnant or lactating female

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Progression Free Survival

    Overall Response Rate

    Toxicity evaluation

    Quality of Life

    Trial Keywords

    Head and neck cancer

    Squamous cell carcinoma

    Metastatic

    Recurrent

    Phase II

    Carboplatin

    Paclitaxel

    Cetuximab