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

NCT02124707 | Completed Phase 2 Results DMC

• 1 other identifier: LCCC 1330
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Head and neck cancer; Squamous cell carcinoma; Metastatic; Recurrent; Phase II; Carboplatin; Paclitaxel; Cetuximab

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival

  Overall survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from D1 of treatment under this protocol until death as a result of any cause.

  36 months

Secondary Outcomes (4)

• Median Progression Free Survival

  36 months

• Overall Response Rate by Participants

  6 weeks

• Incidence of Adverse Events

  18 weeks

• Head and Neck Quality of Life Assessments

  Baseline, End of treatment (EOT), First follow-up visit (8-12 weeks after EOT)

Study Arms (1)

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.

Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Cetuximab DRUG

400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.

Also known as: Erbitux

Carboplatin, Paclitaxel and Cetuximab

Paclitaxel DRUG

135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.

Also known as: Taxol

Carboplatin, Paclitaxel and Cetuximab

Carboplatin DRUG

AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.

Also known as: Paraplatin

Carboplatin, Paclitaxel and Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or lactating female

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (2)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Bon Secours Virginia Health System

Midlothian, Virginia, 23114, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Neoplasm Metastasis; Recurrence

Interventions

Cetuximab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Robin Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

robin_v_johnson@med.unc.edu

919-966-1125

Study Officials

• Jared Weiss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: June 16, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Locations

US (2)