Tarceva (Erlotinib) - Summary

TARCEVA SUMMARY

TARCEVA (erlotinib) is a Human Epidermal Growth Factor Receptor Type 1/Epidermal Growth Factor Receptor (HER1/EGFR) tyrosine kinase inhibitor.

TARCEVA (erlotinib) is indicated for the following:

Non-Small Cell Lung Cancer

TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.

Pancreatic Cancer

TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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NEWS HIGHLIGHTS

Published Studies Related to Tarceva (Erlotinib)

Randomized trial of erlotinib plus whole-brain radiotherapy for NSCLC patients with multiple brain metastases. [2014]
and its direct effect on brain metastases and systemic activity... CONCLUSIONS: Our study showed no advantage in nPFS or OS for concurrent erlotinib

ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. [2013]
regimen with bevacizumab for advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of erlotinib to bevacizumab significantly improved PFS

An evaluation of the possible interaction of gastric acid suppressing medication and the EGFR tyrosine kinase inhibitor erlotinib. [2013]
participants... CONCLUSION: This retrospective analysis found that the co-administration of AS

A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). [2013]
agents in platinum-pretreated non-small-cell lung cancer (NSCLC)... CONCLUSIONS: The addition of sunitinib to erlotinib did not significantly improve

Symptom and quality of life benefit of afatinib in advanced non-small-cell lung cancer patients previously treated with erlotinib or gefitinib: results of a randomized phase IIb/III trial (LUX-Lung 1). [2013]
in a double-blind, randomized, phase IIb/III trial (LUX-Lung 1)... CONCLUSION: In the LUX-Lung 1 trial, the addition of afatinib to BSC

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Clinical Trials Related to Tarceva (Erlotinib)

Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma [Completed]
This trial was originally designed and powered to compare biomarker modulation in the neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical response to erlotinib in the adjuvant setting. Since implementing the trial in late 2005, The investigators have encountered significant obstacles to implementing the adjuvant therapy phase of the trial.

- Barriers included:

1. disease recurrence 2. patient refusal to take the agent 3. patient refusal to travel to Pittsburgh for clinical evaluations. Given the institutional challenges to implement and complete the adjuvant portion, the investigators have decided to change the primary endpoint to a biomarker modulation endpoint. To achieve this goal, the investigators determined that they needed 39 paired tissue specimens (see statistical justification below). The central hypothesis to be tested in this study is that persistent activation of parallel and/or downstream pathways contributes to tumor progression in the setting of EGFR blockade. While not all head and neck squamous cell carcinoma (HNSCC) patients will respond to EGFR targeting, the optimal strategy to identify those subjects whose tumors are sensitive to EGFR inhibition remains unknown. The primary objective is centered around the concept of tumor biomarkers which may be modulated by EGFR and Cox-2 inhibitors and may serve as future therapeutic targets for therapy. To this end patients on this trial will be randomly assigned to one of three arms to receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative period, for group differences, for treatment effects and for further understanding of protein signaling pathways. Sample size for the primary objective Modification of Statistical Design: The primary endpoint is the difference between pre (biopsy) and post (surgery). There are 3 hypotheses of interest: (1) placebo vs erlotinib alone, (2) placebo versus erlotinib plus sulindac, and (3) erlotinib vs erlotinib + sulindac. With a randomization in a 3: 5:5 ratio, we have 88% power, alpha = .01 for an omnibus test to show between-group differences of 1 log exist. This requires 39 patients. Basically, 39 patients will provide the ability to detect a one log difference between any 2 of the 3 groups in pre-post change.

Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205 [Terminated]
Patients that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide will be allowed to participate in this study to assess the safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma.

TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) [Active, not recruiting]
The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control Non-Small Cell Lung Cancer (NSCLC). The safety of this combination treatment will also be studied. Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib. Primary Objective: Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations. Secondary Objectives: 1. Investigate associations between EGFR expression and toxicity, response, overall survival, and progression 2. Estimate overall survival of patients on the study regimen (one and two year rates, median survival). 3. Estimate the time to disease progression of patients on the study regimen (one and two year rates) 4. Estimate the treatment response rate of patients on the study regimen (complete and partial response rates)

Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma [Completed]
The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

Tarceva With Chemoradiation and Adjuvant Chemotherapy for Resectable Pancreatic Cancer [Active, not recruiting]
This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 by mouth twice daily (PO BID) (5 days on/2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50. 4 Gy in 28 fractions after pancreatectomy (dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.

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Reports of Suspected Tarceva (Erlotinib) Side Effects

Death (648),  Diarrhoea (137),  Rash (126),  Disease Progression (66),  Neoplasm Malignant (66),  Fatigue (58),  Nausea (53),  Incorrect Dose Administered (53),  Decreased Appetite (52),  Dyspnoea (52), more >>