Back to results

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

Primary Purpose

Squamous Cell Carcinoma, Head and Neck Cancer, Recurrent Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Erbitux

Taxotere

Low Dose Fractionated Radiation Therapy

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring SCCHN, Head and Neck Cancer, Squamous Cell Carcinoma, Recurrent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erbitux, Taxotere, LD Fractionated RT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Study Participants Experiencing Treatment-Related Toxicity

Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity: Acute toxicity is defined as toxicity occurring within 90 days of start of therapy. Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.

Estimated Progression-Free Survival (PFS)

Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.

Estimated Overall Survival (OS)

Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).

Full Information

NCT ID

NCT01794845

First Posted

February 14, 2013

Last Updated

March 31, 2017

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT01794845

Brief Title

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

Official Title

Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Early termination due to lack of efficacy (overall response)

Study Start Date

June 3, 2013 (Actual)

Primary Completion Date

June 7, 2016 (Actual)

Study Completion Date

June 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The investigator's approach is based on the following reasons: Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest. LDFRT will render enhanced bax activation mediated mode of cell death. Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death. The toxicity profile is expected to be minimal. Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma, Head and Neck Cancer, Recurrent Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erbitux, Taxotere, LD Fractionated RT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erbitux

Other Intervention Name(s)

Cetuximab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Taxotere

Other Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Low Dose Fractionated Radiation Therapy

Other Intervention Name(s)

LDFRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR) of Participants

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Study Participants Experiencing Treatment-Related Toxicity

Description

Time Frame

Up to 6 years

Title

Estimated Progression-Free Survival (PFS)

Description

Time Frame

Up to 6 years

Title

Estimated Overall Survival (OS)

Description

Time Frame

Up to 6 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew C Abramowitz, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs