NCT00599131 · REGISTRY CONDITION SEARCH

Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2015-12-03

The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Patients Achieving Histologic Complete Response

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outcome · POSTED

The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.

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outcome · POSTED

The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.

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outcome · POSTED

Overall Survival Time

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outcome · POSTED

The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx. * Disease must be Stage III or IV. * Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy. * Patients must undergo pre-treatment endoscopic tumor staging and CT scanning. * ECOG Performance status 0-2 * Pre-treatment laboratory criteria: * WBC \> or = to 3500/ul, granulocyte \> or = to 1500/ul. * Platelet count \> or equal to 100,000/ul. * Calculated or measured creatinine clearance \> or = to 60 cc/min. * Total Bilirubin \< or = to 1.5 X ULN. * AST and ALT \< or = to 2.5 X ULN. * Patients must give documented informed consent to participate in this study. Exclusion Criteria: * Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years. * Prior head and neck radiation or prior chemotherapy. * Documented evidence of distant metastases. * Active infection. * Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment. * Patients residing in prison. * Age \< 18 years. * Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible. * Patients with prior radiation to the head and neck. * Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy with a tyrosine-kinase inhibitor. * Patients with Grade \> 2 peripheral neuropathy. * Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
intervention Names
Drug: Cisplatin
Drug: Cetuximab
Drug: 5-Fluorouracil
Drug: Docetaxel
label
Chemotherapy/Radiation/Surgery
type
EXPERIMENTAL

interventions

arm Group Labels
Chemotherapy/Radiation/Surgery
description
1\. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a \< 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk features (i.e. extracapsular spread, \> 2 positive lymph nodes, perineural invasion, or positive margins). Cisplatin will either be dosed a 100 mg/m2 every 21 days or 40 mg/m2 weekly at the discretion of the prescribing physician.
name
Cisplatin
other Names
Platinol®-AQ
type
DRUG
arm Group Labels
Chemotherapy/Radiation/Surgery
description
1\. Cetuximab will be administered at 400 mg/m2 on Day 20 (2 hour administration). 2. Cetuximab will be administered in combination with radiation therapy to those subjects who had a Partial or Complete response after the first cycle of the chemotherapy regimen is administered. The dosage for these administrations is 250 mg/m2 over sixty minutes and it will be administered for six weeks.
name
Cetuximab
other Names
C-225
Erbitux®
type
DRUG
arm Group Labels
Chemotherapy/Radiation/Surgery
description
5-FU will be administered 750 mg/m2 in 0.9% normal saline as a 24-hour continuous infusion, days #1-4.
name
5-Fluorouracil
other Names
Adrucil®
Carac™
Efudex®
Fluoroplex®
5-FU
FU
type
DRUG
arm Group Labels
Chemotherapy/Radiation/Surgery
description
75 mg/m2 by I.V. over one hour on Day # 1 only
name
Docetaxel
other Names
Taxotere®
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 4
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
measure
Percentage of Patients Achieving Histologic Complete Response
time Frame
3 years

secondary Outcomes

description
To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.
measure
The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.
time Frame
Day 23
description
To evaluate the quality of life (QOL).
measure
The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.
time Frame
24 months
description
To determine the overall survival rates compared to the overall survival rates of historical controls.
measure
Overall Survival Time
time Frame
3 years
description
To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.
measure
The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia
time Frame
3 years.

Full study description

brief Summary: The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).
detailed Description: In this study one cycle of chemotherapy will be administered and then those subjects who respond well to that cycle will be started on radiation therapy along with chemotherapy and those that don't respond well to the initial cycle of chemotherapy, will undergo a total laryngectomy (surgery to remove the voice box) followed by radiation therapy. The initial cycle of chemotherapy consists of the drugs Taxotere, Cisplatin, and 5-Fluorouracil (this combination is known as TPF). Then on Day 20 of the study, the subjects will be administered another chemotherapy agent called cetuximab (a.k.a. C-225). It will then be determined if the patient's response to the chemotherapy was favorable by examining the patient's tumor with an endoscopy. If the response is determined to be good, then the patient will continue with a chemotherapy regimen with the addition of radiation therapy combination. If the patient's response to the chemotherapy is determined to be less than favorable, then the patient will be advised to undergo salvage surgery (a.k.a. laryngectomy) to remove their voice box and then undergo radiation therapy treatment. Additionally, tumor tissue samples and blood will be studied to see if there are special molecular markers that help predict when a tumor will respond to chemotherapy and radiation treatment.

Source references

Source notices and limitations

Discovery and provenance

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id
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nct id
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occurrences
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end
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exact text
NCT00599131
start
0
offset unit
unicode_code_points
query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice