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

NCT00573989 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: IRB00003457P30CA012197CCCWFU-60107
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)

  Dose at which 100% of participants tolerated the dose

  56 Days

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

  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.

  1 year

Secondary Outcomes (9)

• Median Progression Free Survival

  2 years

• Median Overall Survival

  up to 5 years

• Overall Survival

  1 and 2 years

• Evaluation of Acute and Chronic Toxicity

  1 year

• Change in Quality of Life- FACT H&N

  baseline and 12 months

Study Arms (1)

Erlotinib

EXPERIMENTAL

Erlotinib

Drug: erlotinib hydrochloride; Drug: pemetrexed disodium; Procedure: quality-of-life assessment; Radiation: intensity-modulated radiation therapy

Interventions

erlotinib hydrochloride DRUG

Erlotinib

pemetrexed disodium DRUG

Erlotinib

quality-of-life assessment PROCEDURE

Erlotinib

intensity-modulated radiation therapy RADIATION

Erlotinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UNC Linberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Erlotinib Hydrochloride; Pemetrexed; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Mercedes Porosnicu
• Organization: Wake Forest University Health Sciences

mporosni@wakehealth.edu

336-716-8664

Study Officials

• Mercedes Porosnicu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Kathryn M. Greven, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: March 1, 2008
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 3, 2019
• Results First Posted: December 13, 2018

Record last verified: 2018-12

Locations

US (2)