Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

NCT01794845 | Terminated Phase 2 Results DMC

• 1 other identifier: 20090467
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Conditions

Squamous Cell Carcinoma; Head and Neck Cancer; Recurrent Disease

Keywords

SCCHN; Head and Neck Cancer; Squamous Cell Carcinoma; Recurrent

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) of Participants

  ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.

  Up to 6 months from End of Treatment, about 9 months

Secondary Outcomes (3)

• Number of Study Participants Experiencing Treatment-Related Toxicity

  Up to 6 years

• Estimated Progression-Free Survival (PFS)

  Up to 6 years

• Estimated Overall Survival (OS)

  Up to 6 years

Study Arms (1)

Erbitux, Taxotere, LD Fractionated RT

EXPERIMENTAL

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)

Drug: Erbitux; Drug: Taxotere; Radiation: Low Dose Fractionated Radiation Therapy

Interventions

Erbitux DRUG

Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.

Also known as: Cetuximab

Erbitux, Taxotere, LD Fractionated RT

Taxotere DRUG

Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.

Also known as: Docetaxel

Erbitux, Taxotere, LD Fractionated RT

Low Dose Fractionated Radiation Therapy RADIATION

Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.

Also known as: LDFRT

Erbitux, Taxotere, LD Fractionated RT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
• The recurrence must have defined bi- or uni-dimensional measurements.
• Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
• The patient must not be a candidate for surgical resection.
• Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
• Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine \< 1.5 mg/dl within 3 weeks prior to registration.
• Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If \> 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
• Patients must sign a study-specific informed consent form prior to study entry.

You may not qualify if:

• Distant metastases outside of the head and neck.
• Primary disease in the nasopharynx or the salivary gland.
• Other concurrent invasive malignancies.
• Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
• Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
• Pre-existing grade ≥ 2 peripheral sensory neuropathy
• Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
• Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms; Recurrence

Interventions

Cetuximab; Docetaxel

Condition Hierarchy (Ancestors)

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

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

Limitations and Caveats

Data analyzed for 4 out of 5 study participants due to 1 study participant withdrawing prior to receiving study therapy.

Results Point of Contact

• Title: Matthew C. Abramowitz MD
• Organization: University of Miami

MAbramowitz@med.miami.edu

305-243-4319

Study Officials

• Matthew C Abramowitz, MD

  University of Miami

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 20, 2013
• Study Start: June 3, 2013
• Primary Completion: June 7, 2016
• Study Completion: June 7, 2016
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)