Phase 2
N=119
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
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
Bottom Line
View on ClinicalTrials.gov: NCT01064479 ↗Enrolled (actual)
119
Serious AEs
56.3%
Results posted
Jan 2022
Primary outcome: Primary: Progression Free Survival (PFS) — 6.08; 4.4 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Cisplatin (Drug); Docetaxel (Drug); Erlotinib Hydrochloride (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Placebo (Other); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
6.08; 4.4 | — |
| SECONDARY Overall Survival (OS) |
16.95; 13.67 | — |
| SECONDARY Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR]) |
4; 5; 27; 19; 8; 13 | — |
| SECONDARY Disease Control (CR + PR + Stable Disease [SD]) |
47; 41 | — |
| SECONDARY Rash Rates |
20; 4 | — |
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.
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) = = 1.5 x 10^9/L
- Platelet count >= 100 x 10^9/L
- Total bilirubin = = 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
Data sourced from ClinicalTrials.gov (NCT01064479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.