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

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Paclitaxel

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