Cetuximab + Taxotere With Low Dose Fractionated Radiation... | NCT01794845

NCT01794845

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	Erbitux, Taxotere, LD Fractionated RT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

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.

Name	Affiliation	Role
Matthew C Abramowitz, MD	University of Miami	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States

Arm/Group Information

ID	Title	Description
FG000	Erbitux, Taxotere, LD Fractionated RT	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): 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. Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Erbitux, Taxotere, LD Fractionated RT	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): 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. Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical		Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Erbitux, Taxotere, LD Fractionated RT	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): 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. Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Erbitux, Taxotere, LD Fractionated RT	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): 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. Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. 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.

ID	Term
D002294	Carcinoma, Squamous Cell
D006258	Head and Neck Neoplasms
D012008	Recurrence

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D000068818	Cetuximab
D000077143	Docetaxel

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins