Erlotinib Clinical Trials

What Is Erlotinib?

Erlotinib is an FDA-approved medication primarily used for the treatment of non-small cell lung cancer (NSCLC) and other cancers. It is a type of drug known as a tyrosine kinase inhibitor (TKI). Erlotinib works by blocking the activity of a protein called the epidermal growth factor receptor (EGFR), which is found on the surface of many tumor cells. EGFR plays a key role in regulating the growth, survival, and differentiation of these cells. By inhibiting EGFR, erlotinib may help to stop tumors from growing.

Beyond its approved uses, erlotinib is also being investigated in clinical trials for a variety of other advanced solid tumors and hematological malignancies. These studies aim to explore its safety and effectiveness when used alone or in combination with other anti-cancer therapies.

Uses and Conditions Under Study

Erlotinib has been extensively studied in clinical trials for various cancers, with a significant focus on lung cancers. Across 245 trials, erlotinib is being investigated for conditions such as Non-Small Cell Lung Cancer, Lung Cancer, Carcinoma, Non-Small-Cell Lung, and Non-Squamous Non-Small Cell Lung Cancer. These studies aim to understand how blocking the EGFR protein, which is often present in these tumors, can slow disease progression or improve patient outcomes, particularly in cases where the cancer has progressed after initial chemotherapy.

Another major area of investigation for erlotinib is pancreatic cancer, with 39 trials exploring its potential. Researchers are studying whether adding erlotinib, an EGFR-blocking drug, to standard chemotherapy regimens like gemcitabine and nab-paclitaxel can be safe, tolerable, and effective for individuals with advanced pancreatic cancer.

Erlotinib is also being evaluated for its role in other advanced cancers. This includes 20 trials for Head and Neck Cancer, 19 trials for general Cancer, and 16 trials for Breast Cancer. These studies often focus on patients with advanced disease, investigating erlotinib as a targeted therapy that interferes with specific molecules needed for tumor growth. Other conditions under study include biliary tract carcinoma, malignant peritoneal mesothelioma, glioblastoma, familial adenomatous polyposis, and myelodysplastic syndrome.

Dosing

Erlotinib is typically administered orally. It has been studied in various strengths, including 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg capsules or tablets. For example, some trials have used an oral dose of 50 mg, given as two 25 mg capsules, while other studies have explored a standard dose of 150 mg daily.

Dosage can vary depending on the specific study and condition being investigated. In some trials, erlotinib dosage is initiated at a lower strength, such as 50 mg, and then escalated to 75 mg and 100 mg over several weeks, depending on patient tolerance. It is often taken once daily by mouth. While erlotinib is FDA-approved for certain cancers, its use in many ongoing trials is investigational, and doses may be adjusted based on tolerability and the specific drug combinations being tested.

Side Effects

In clinical trials, the most common side effect reported by patients taking Erlotinib was diarrhea. Approximately 49.5% of patients on Erlotinib experienced diarrhea, compared to 38.2% of those on placebo. Rash was also frequently observed, affecting 47.3% of patients taking Erlotinib versus 32.0% on placebo.

Other common side effects included:

• Fatigue: 31.2% of patients on Erlotinib experienced fatigue, compared to 26.3% on placebo.
• Nausea: 24.4% of patients on Erlotinib reported nausea, while 21.6% on placebo did.
• Decreased appetite: This was reported by 24.8% of patients on Erlotinib, which was slightly less than the 25.5% on placebo.
• Dermatitis acneiform (acne-like rash): 19.4% of patients on Erlotinib experienced this, compared to 17.4% on placebo.
• Vomiting: 17.7% of patients on Erlotinib experienced vomiting, versus 16.1% on placebo.
• Dry skin: 17.2% of patients on Erlotinib reported dry skin, compared to 14.8% on placebo.

Clinical Trial Results

Erlotinib has been studied in several clinical trials for various cancers. The results below highlight key findings from these studies.

Recurrent Malignant Glioma or Meningioma (NCT00045110)

In a Phase II study involving patients with newly diagnosed glioblastoma multiforme (GBM) after radiation therapy, 57% of participants were alive after one year. The median overall survival for these patients was 14 months.

Stage IV Breast Cancer (Erlotinib Hydrochloride and Bevacizumab) (NCT00054132)

In a study combining Erlotinib with bevacizumab for patients with Stage IV breast cancer, the overall response rate (defined as complete or partial response) was approximately 54%. Patients experienced a median time to progression of 11 weeks. For those who responded to treatment, the duration of response was a median of 52 months.

Stage IV or Recurrent Breast Cancer (Erlotinib Plus Docetaxel) (NCT00054275)

A trial investigating Erlotinib combined with docetaxel in patients with Stage IV or recurrent breast cancer reported a median overall survival of 22.3 months. The median progression-free survival, meaning the time patients lived without their cancer worsening, was 8.4 months.

Ovarian Carcinoma (Erlotinib Plus Carboplatin and Paclitaxel) (NCT00059787)

In a study evaluating Erlotinib alongside carboplatin and paclitaxel for ovarian carcinoma, the median progression-free survival was 34.3 months.

Currently Recruiting Trials

Where to Participate

• Atlanta, Georgia (3 sites)
• Bethesda, Maryland (2 sites)
• Rochester, Minnesota
• New Brunswick, New Jersey
• Mineola, New York
• New York, New York
• Chapel Hill, North Carolina
• Columbus, Ohio
• Pittsburgh, Pennsylvania
• La Jolla, California

Development Timeline