Clinical trial NCT01064479: Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Official title: A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Squamous Cell Carcinoma of the Hypopharynx
Metastatic Squamous Cell Carcinoma of the Larynx
Metastatic Squamous Cell Carcinoma of the Oral Cavity
Metastatic Squamous Cell Carcinoma of the Oropharynx
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-08
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.

Detailed description: PRIMARY OBJECTIVES:

I. Assess the efficacy of adding erlotinib hydrochloride (erlotinib) to chemotherapy to improve progression free survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck.

SECONDARY OBJECTIVES:

I. Evaluate overall survival, response rate, disease control rate, and duration of response by treatment with or without erlotinib.

II. Evaluate quality of life (patient reported outcomes) by treatment with or without erlotinib.

III. Evaluate the safety profile of erlotinib in combination with chemotherapy. IV. Correlate the occurrence of erlotinib-induced rash with outcomes. V. To evaluate the steady-state pharmacokinetics of erlotinib. VI. To explore the prognostic and predictive value of epidermal growth factor receptor related biomarkers and other biomarkers, including blood and tissue proteomic and blood and tissue genomic markers, that may be associated with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive docetaxel intravenously (IV) over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1, and erlotinib hydrochloride orally (PO) daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.

ARM B: Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.

After completion of study treatment, patients are followed up at 30 days.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, hypopharynx or larynx; metastatic or recurrent lesions of the nasopharynx and sinus are excluded
* Radiologically measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes are required to be \>= 15 mm in size (short axis diameter)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Platelet count \>= 100 x 10\^9/L
* Total bilirubin =\< upper limit of normal (ULN) (excluding Gilbert's disease)
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x ULN
* Alkaline phosphatase =\< 2.5 x ULN
* Serum creatinine =\< 1.5 x ULN
* Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =\< 14 days prior to treatment initiation
* Written informed consent to participate in the study according to the investigational review board (IRB) or independent ethics committee (IEC)

Exclusion Criteria:

* Histology other than squamous cell carcinoma
* Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx
* Prior palliative chemotherapy for metastatic or recurrent disease
* Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization
* Patients with known, untreated brain metastases; patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable
* Pre-existing peripheral neuropathy \>= grade 2
* History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis); patients requiring feeding tubes are permitted
* Other active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanoma
* Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician
* History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80
* Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Women who are pregnant or breast-feeding and women or men not practicing effective birth control

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
timeFrame: 5 years
measure: Disease Control (CR + PR + Stable Disease [SD])
timeFrame: 5 years
measure: Rash Rates
timeFrame: 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Regional Care Center-Katy
state: Texas
city: Nassau Bay
country: United States
facility: MD Anderson Regional Care Center-Bay Area
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson Regional Care Center-Sugar Land
state: Texas
city: The Woodlands
country: United States
facility: MD Anderson Regional Care Center-The Woodlands
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xiuning Le
role: PRINCIPAL_INVESTIGATOR
References: