Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial
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
| Verified date | October 2023 |
| Source | M.D. Anderson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 123 |
| Est. completion date | November 3, 2020 |
| Est. primary completion date | November 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall Survival (OS) | Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals. | 5 years | |
| Secondary | Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR]) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions | 5 years | |
| Secondary | Disease Control (CR + PR + Stable Disease [SD]) | Complete Response (CR) + Partial Response (PR) + Stable disease | 5 years | |
| Secondary | Rash Rates | Participants with a Rash of at least grade 2 within cycle 1. | 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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