Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have locally advanced, recurrent, or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Docetaxel; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria:

• Recurrent

• Metastatic

• Locally advanced and determined to be incurable by surgery or radiotherapy

• Measurable disease

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas level greater than 50 mm Hg

• No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)

• No congenital abnormality (e.g., Fuch's dystrophy)

• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)

• No abnormal corneal sensitivity test (Schirmer test or similar tear production test)

• Able to take oral medication

• No requirement for IV alimentation

• No active peptic ulcer disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No significant traumatic injury within the past 21 days

• No prior allergic reactions to compounds of similar chemical or biological composition to study drugs

• No grade 2 or greater persistent peripheral neuropathy

• No other concurrent uncontrolled illness that would preclude study participation

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No prior immunotherapy for head and neck cancer

• No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting

• No more than 1 prior chemotherapy regimen for metastatic disease

• No prior docetaxel (phase II only)

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No prior hormonal therapy for head and neck cancer

• Prior external beam radiotherapy allowed

• At least 4 weeks since prior radiotherapy and recovered

• More than 21 days since prior major surgery

• No prior surgery affecting gastrointestinal absorption

• No prior epidermal growth factor receptor-targeting therapy

• No other concurrent investigational agents

• No other concurrent anticancer therapies or agents

• No concurrent combination antiretroviral therapy for HIV-positive patients