CLINICAL TRIAL

afatinib for Carcinoma, Squamous Cell

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · New Haven, CT

This study is evaluating whether a combination of two drugs may help treat head and neck cancer.

See full description

About the trial for Carcinoma, Squamous Cell

Eligible Conditions
Head and Neck Neoplasms · Neoplasms, Squamous Cell · Squamous Cell Cancers of the Head and Neck · Carcinoma, Squamous Cell

Treatment Groups

This trial involves 2 different treatments. Afatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
cetuximab
DRUG
afatinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Afatinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Squamous Cell or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic, recurrent or locally advanced and not treatable with curative intent.
Previous treatment with a platinum-based regimen or immune checkpoint inhibitor or both.2-week washout period prior to treatment start will be required.
Patients who have experienced progression of disease within 6 months following completion of a platinum-based chemoradiation in the definitive or adjuvant setting will be permitted.
Prior cetuximab permitted if it was given as part of multi-modality therapy for initial treatment of locally advanced disease.
Measurable disease based on RECIST v 1.1. Baseline measurements and evaluations must be obtained within 4 weeks of enrollment. Disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy.
ECOG performance status ≤2
Hemoglobin ≥ 8 g/dl.
Absolute neutrophil count (ANC) ≥1000 / mm3.
Platelet count ≥75,000 / mm3.
Estimated creatinine clearance > 45ml / min.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2.5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2.5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2.5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether afatinib will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of 1 year follow-up.

Progression-free survival in weeks
1 YEAR FOLLOW-UP
We will use Kaplan-Meier survival analysis to estimate the median PFS in the cohort.
1 YEAR FOLLOW-UP
Duration of response in weeks
1 YEAR FOLLOW-UP
1 YEAR FOLLOW-UP
Overall survival in months
1 YEAR FOLLOW-UP
Measured by a monthly phone calls. We will use Kaplan-Meier survival analysis to estimate the median and OS in the cohort.
1 YEAR FOLLOW-UP
Tumor shrinkage
DISEASE PROGRESSION OR END OF TREATMENT (UP TO 2 YEARS)
Objective Response Rate (Complete Response + Partial Response), defined by tumor shrinkage (mm), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
DISEASE PROGRESSION OR END OF TREATMENT (UP TO 2 YEARS)
Exploratory biomarker analysis
UP TO 2 YEARS
Analysis of tumor-tissue from biopsies obtained at baseline, after four weeks of treatment with the combination, and again at disease progression or end of treatment
UP TO 2 YEARS
Toxicity assessed with National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
UP TO 2.5 YEARS
UP TO 2.5 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes carcinoma, squamous cell?

The risk factors we have identified from our retrospective analysis of 5,575 patients with SCC and 2,827 controls are similar with those presented in other SCC studies, but the magnitude of risk varies considerably from one population to another. The risk factors we have identified could serve as a surrogate for hereditary cancer studies.

Anonymous Patient Answer

Can carcinoma, squamous cell be cured?

The overall incidence of carcinoma, squamous cell was 1.18 per 100,000 person-years in Shanghai in 1997, and the incidence rates increased to 14.11 per 100,000 person-years in Shanghai in 2005. The incidence of carcinoma, squamous cell in non-smokers was 8.27 per 100,000 person-years in Shanghai in 1997, and the incidence rate increased to 18.89 per 100,000 person-years in Shanghai in 2005. The incidence rates of carcinoma, squamous cell in Shanghai were higher than the national incidence rates (1.01 per 100,000 person-years in 2007), and also higher than the national average of 4.

Anonymous Patient Answer

What are the signs of carcinoma, squamous cell?

Carcinoma, squamous cell typically causes the same symptoms as a viral illness such as the common cold. However this disease spreads in many different ways, and must be carefully evaluated.\n\nPatients may also develop a fever, feeling ill after eating or drinking fluids, or have shortness of breath. Some might have skin problems such as itching and itchy, painful rashes and other dermatological symptoms. Patients experiencing these symptoms may have trouble eating, trouble sleeping or they might stop taking their medicines. \n\nThere are various approaches to assessing the severity of symptoms.

Anonymous Patient Answer

What is carcinoma, squamous cell?

The eponymous carcinoma, squamous cell, can be grouped into various subtypes under which it can be classified depending on the type of epithelial tissue in which it grew. Most commonly, it is a squamous cell carcinoma, or "carcinoma, squamous cell". It also refers to cancers that are related to squamous cell epithelia, such as buccal, palate, urethral, vulvar/vaginal, cervical and laryngeal.

Anonymous Patient Answer

What are common treatments for carcinoma, squamous cell?

Cancers can be divided into three major types: lung (carcinoma, squamous cell and adenocarcinoma, squamous cell), prostate (carcinoma, adenocarcinoma, adenocarcinoma in situ and carcinoma, small cell, adenocarcinoma in situ) and brain (carcinomas and gliomas). The most common treatment for these cancers is surgery, although radiation therapy is also sometimes used. The presence of symptoms is an important, though insufficient, indication for a more invasive procedure.

Anonymous Patient Answer

How many people get carcinoma, squamous cell a year in the United States?

Approximately 100,000 cases of SCC are diagnosed a year in the US. This makes it the eighth leading cause of cancer death and a main cause of nonskin cancer in males. The most frequent sites of SCC are the prostate, the pharynx, and the tongue. The second most common site of SCC is the skin, specifically the head and neck area (27%) and the bladder (25%). The average age of presentation is 69 yr for cancers of the head and neck areas, 63 yr for the trunk and proximal extremities, and 71 yr for the distal extremities. There were no differences among racial/ethnic groups and age groups with respect to cancer presentation.

Anonymous Patient Answer

Is afatinib typically used in combination with any other treatments?

In general, patients often take multiple anticancer therapies. However, only 0.4% of the patients take afatinib as monotherapy. Thus, this type of therapeutic combination is not well suited for the vast majority of patients; some patients may show a significantly better quality of life if adjuvant treatment is initiated. Only a minority of patients (1%) take afatinib as monotherapy.

Anonymous Patient Answer

What is the survival rate for carcinoma, squamous cell?

The survival rate of the patients who underwent radical surgery was 50.8 %, including both locoregional recurrences and distant metastasis. Only the age and surgical approach were associated with prognosis. The survival rate of the patients who underwent local excision only was 42.2 %. There were no locoregional recurrences. The survival rate of the patients who underwent curative surgery was 61.4 %, including both locoregional recurrences and distant metastasis. The survival rate of the patients who underwent local excision only was 32.4 %. The patients who underwent partial omentectomy had a higher mortality rate.

Anonymous Patient Answer

How serious can carcinoma, squamous cell be?

We report a high prevalence of lung metastases (9.9%), which is very different from the reported prevalences of carcinoma, squamous cell in the western world. The presence of lymph node metastases and the absence or number of distant metastases are very important prognostic factors in carcinoma, squamous cell.

Anonymous Patient Answer

Has afatinib proven to be more effective than a placebo?

In patients with a metastatic lung cancer the addition of afatinib to chemotherapy showed a significant improvement of PFS with respect to patients who received chemotherapy alone and a non-significant improvement of OS compared with those who received a placebo. On the basis of limited survival data and the lack of clear-cut advantages, we think further studies on afatinib should be performed to confirm the results.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, squamous cell?

Clinical trials might be appropriate for a select group of patients as they represent the potential for high quality research in this specific area as well as offering some control over treatments.

Anonymous Patient Answer

What are the chances of developing carcinoma, squamous cell?

(1) Only 7% of women under the age of 30 have a carcinoma. (2) The chance of developing a carcinoma increases in younger and older women: 7% and 14% respectively (3) The likelihood that a woman is developing a carcinoma is similar regardless of her ethnicity or marital status (4) The development of a carcinoma is positively correlated with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), colorectal cancer, ovarian cancer, and uterine cancer (5) Compared to other women, women in early life develop breast and intestinal cancer at much higher rates than other countries. (6) Current tobacco smoking behavior is closely related to the likelihood of the development of cancer.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Squamous Cell by sharing your contact details with the study coordinator.