NCT00573989 · REGISTRY CONDITION SEARCH

Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer

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

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2019-01-03

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with intensity-modulated radiation therapy and pemetrexed and to see how well they work in treating patients with recurrent or second primary head and neck cancer.

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

Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)

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outcome · POSTED

Progression-free Survival (PFS) at 1 Year (Phase II)

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outcome · POSTED

Median Progression Free Survival

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outcome · POSTED

Median Overall Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Evaluation of Acute and Chronic Toxicity

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outcome · POSTED

Change in Quality of Life- FACT H&N

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outcome · POSTED

Change in Quality of Life: PSS-HN

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outcome · POSTED

Change in Quality of Life: MDADI

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outcome · POSTED

Evaluation of Biomarkers

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outcome · POSTED

Objective Tumor Response

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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: \* Histologically or cytologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the head and neck, including any of the following: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Recurrent neck metastases with unknown primary Exception from pathology confirmation of tumor recurrence is accepted for patients who originally had pathologically confirmed SCC of the Head and Neck, the new tumor is located in the head and neck area and it is clinically considered as a recurrence of the original tumor, and a tumor biopsy is technically difficult and would expose the patient to unjustified risk. The treating physicians should agree and document the clinical definition of tumor recurrence and should document the increased risk for biopsy. * Measurable disease by CT scan or MRI OR evaluable disease * No definitive evidence of distant metastasis * Unresectable disease by a preliminary ENT evaluation OR refused surgery * Patients may have received chemotherapy as a component of their primary tumor treatment but not for recurrent or metastatic disease. No prior treatment with systemic anti-EGFR inhibitors or Pemetrexed is permitted * Has undergone prior head and neck radiotherapy (for SCC of the head and neck) to a dose of ≤ 72 Gy that involved most of the recurrent tumor (\> 75%) OR has a second primary tumor volume in areas previously irradiated to \> 45 Gy * The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 54 Gy (prior plus planned dose) * Must have disease recurrence or persistence for ≥ 6 months after completion of prior radiotherapy * ECOG performance status 0-1 * Age ≥ 18 years * ANC \> 1,500/µL * Platelet count \> 100,000/µL * Total bilirubin \< 1.5 times upper limit of normal (ULN) * AST/ALT \< 2 times ULN * Creatinine \< 1.5 times ULN * Willing and able to take folic acid and vitamin B12 supplementation * Recovered from prior surgery, chemotherapy, or radiotherapy * At least 6 months since prior radiotherapy * At least 5 days since prior aspirin or other non-steroidal anti-inflammatory agents (8 days for long acting agents \[e.g., piroxicam\]) * Fertile patients must use effective contraception Exclusion: * Nasopharyngeal carcinoma * Concurrent uncontrolled illness, including, but not limited to, any of the following: * Ongoing or active infection * Psychiatric illness or social situation that would limit compliance with study requirements * Significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension; unstable angina; recent myocardial infarction \[within the past 3 months\]; uncontrolled congestive heart failure; or cardiomyopathy with decreased ejection fraction) * Active interstitial lung disease * Presence of third space fluid that cannot be controlled by drainage * Other concurrent investigational agents * Pregnant or nursing * HIV positive
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Erlotinib
intervention Names
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Procedure: quality-of-life assessment
Radiation: intensity-modulated radiation therapy
label
Erlotinib
type
EXPERIMENTAL

interventions

arm Group Labels
Erlotinib
name
erlotinib hydrochloride
type
DRUG
arm Group Labels
Erlotinib
name
pemetrexed disodium
type
DRUG
arm Group Labels
Erlotinib
name
quality-of-life assessment
type
PROCEDURE
arm Group Labels
Erlotinib
name
intensity-modulated radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 27
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Dose at which 100% of participants tolerated the dose
measure
Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
time Frame
56 Days
description
Determine Progression Free Survival at 1 year defined as the percentage of patients who are alive at 1 year after beginning of their concurrent re-irradiation and chemotherapy without loco-regional progression of their disease as measured by CT scan or MRI.
measure
Progression-free Survival (PFS) at 1 Year (Phase II)
time Frame
1 year

secondary Outcomes

description
Median Progression Free Survival of participants reported after 2 years.
measure
Median Progression Free Survival
time Frame
2 years
description
Median Overall Survival of participants reported after 2 years.
measure
Median Overall Survival
time Frame
up to 5 years
description
Overall survival of participants reported after 2 years.
measure
Overall Survival
time Frame
1 and 2 years
description
Evaluate acute and chronic toxicity of the combined re-irradiation with radiosensitizing drugs: Pemetrexed and Erlotinib. Adverse events with Common Toxicity Criteria grades of 4 and 5 are reported for phase I and II.
measure
Evaluation of Acute and Chronic Toxicity
time Frame
1 year
description
The Functional Assessment of Cancer Therapy-Head and Neck (FACT H\&N) consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain. Score range is 0-156. Higher scores denotes better outcomes
measure
Change in Quality of Life- FACT H&N
time Frame
baseline and 12 months
description
The Performance Status Scale for Head \& Neck Cancer Patients (PSS-HN) is s designed to evaluate performance in areas of functioning most likely affected by head and neck cancer and its treatment, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated from 0 to 100, with higher scores indicating better performance
measure
Change in Quality of Life: PSS-HN
time Frame
baseline and 6 months
description
The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.
measure
Change in Quality of Life: MDADI
time Frame
baseline and 12 months
measure
Evaluation of Biomarkers
time Frame
throughout study completion, up to 2 years
description
Objective Tumor Response reported on participants at 1 year (complete, partial, progression, or stable response).
measure
Objective Tumor Response
time Frame
1 year

Full study description

brief Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with intensity-modulated radiation therapy and pemetrexed and to see how well they work in treating patients with recurrent or second primary head and neck cancer.
detailed Description: OBJECTIVES: Primary * Evaluate the acute toxicity and feasibility of intensity modulated radiotherapy (IMRT) in combination with radiosensitizing drugs pemetrexed disodium and erlotinib hydrochloride in patients with recurrent or second primary squamous cell carcinoma of the head and neck. (Phase I) * Determine the maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in these patients. (Phase I) * Determine progression-free survival (PFS) at 1 year in these patients. (Phase II) Secondary * Determine median PFS, median overall survival (OS), and OS at 1 and 2 years in these patients. * Determine objective tumor response as measured by CT scan or MRI in these patients. * Evaluate the acute and chronic toxicity of IMRT in combination with radiosensitizing drugs pemetrexed disodium and erlotinib hydrochloride in these patients. * Evaluate the impact of treatment on quality of life as measured by FACT-H\&N, PSS-HN, MD Anderson Dysphagia Inventory (MDADI), and swallowing by direct functional measurements at different time points. * Evaluate the level of phosphorylation of different tyrosine residues within the cytoplasmic domain of EGFR, bound adaptors, as well as markers of downstream pathways activation by nano LC-MS/MS in tumor tissue and correlate with levels of P-AKT and P-ERK by immunohistochemistry and with response to treatment. * Measure the levels of TS and p53 and correlate with treatment response. OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride followed by a phase II study. * Phase I: Patients undergo intensity modulated radiotherapy (IMRT) once daily, 5 days a week, for 6 weeks. Patients receive pemetrexed disodium IV over 10 minutes on day 1 of radiotherapy. Treatment with pemetrexed disodium repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity. * Phase II: Patients undergo IMRT and receive pemetrexed sodium as in phase I. Patients also receive erlotinib hydrochloride at the maximum tolerated dose determined in phase I. Quality of life is assessed at baseline, weekly during treatment, at 1, 6, and 12 months, and then annually thereafter. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice