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

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Pemetrexed

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