Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
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
2 other identifiers
interventional
123
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2010
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2010
CompletedStudy Start
First participant enrolled
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2020
CompletedResults Posted
Study results publicly available
January 25, 2022
CompletedJuly 16, 2024
July 1, 2024
10.8 years
February 5, 2010
November 3, 2021
July 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
5 years
Secondary Outcomes (4)
Overall Survival (OS)
5 years
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
5 years
Disease Control (CR + PR + Stable Disease [SD])
5 years
Rash Rates
5 years
Study Arms (2)
Arm A (combination chemotherapy and erlotinib hydrochloride)
EXPERIMENTALPatients 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.
Arm B (combination chemotherapy and placebo)
ACTIVE COMPARATORPatients 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.
Interventions
Given IV
Given IV
Given IV
Given PO
Optional correlative studies
Optional correlative studies
Given PO
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, 77094, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Xiuning Le, MD, Assistant Professor, Thoracic-Head & Neck Med Onc
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuning Le
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2010
First Posted
February 8, 2010
Study Start
February 5, 2010
Primary Completion
November 3, 2020
Study Completion
November 3, 2020
Last Updated
July 16, 2024
Results First Posted
January 25, 2022
Record last verified: 2024-07