Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT01064479
Last Updated: 2024-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2010-02-05
2020-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A (combination chemotherapy and erlotinib hydrochloride)
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride 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.
Carboplatin
Given IV
Cisplatin
Given IV
Docetaxel
Given IV
Erlotinib Hydrochloride
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Pharmacological Study
Optional correlative studies
Quality-of-Life Assessment
Ancillary studies
Arm B (combination chemotherapy and placebo)
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.
Carboplatin
Given IV
Cisplatin
Given IV
Docetaxel
Given IV
Laboratory Biomarker Analysis
Optional correlative studies
Pharmacological Study
Optional correlative studies
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Interventions
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Carboplatin
Given IV
Cisplatin
Given IV
Docetaxel
Given IV
Erlotinib Hydrochloride
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Pharmacological Study
Optional correlative studies
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Xiuning Le
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2011-03782
Identifier Type: REGISTRY
Identifier Source: secondary_id
2009-0395
Identifier Type: OTHER
Identifier Source: secondary_id
2009-0395
Identifier Type: -
Identifier Source: org_study_id
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