Erlotinib + Tyrosine Kinase Inhibitors for Cancer
Trial Summary
What is the purpose of this trial?
Cancers that return or spread after their first line of treatment are often difficult to treat with limited next step options. Based on preclinical studies, the EGFR-targeting tyrosine kinase inhibitor (TKI) Erlotinib may be better in stopping or slowing the growth of tumors when given in combination with the multitargeting TKI Lenvatinib or Axitinib. Participants will be screened with a physical exam and tests including urine and blood tests, imaging scans, and a test of their heart function. Erlotinib, axitinib, and lenvatinib are all capsules taken by mouth. All participants will take their drugs at home every day. Some participants will take erlotinib plus lenvatinib once a day. Some participants will take erlotinib once a day and axitinib twice a day. Assignment to one of the treatment arms will be determined by the study. Participants will record their doses in a diary. Treatment is given in 28-day cycles. All participants will have 4 clinic visits during their first treatment cycle. After that, they will have a clinic visit at the start of each new cycle. Imaging scans, blood and urine tests, and other tests will be repeated during various clinic visits. Participants will remain in the study for as long as the treatment is helping them. They will have follow-up phone calls after they stop treatment....
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications, specifically strong CYP3A4- and/or CYP1A2-inhibiting or -inducing agents, and agents that increase gastric pH, unless they can be replaced with alternatives. If you are on more than two blood pressure medications, you will also need to adjust your treatment. Please discuss with your doctor to see if your current medications are affected.
What data supports the effectiveness of the drug Lenvatinib in cancer treatment?
What safety information is available for Erlotinib and Axitinib in humans?
Erlotinib and Axitinib are generally well tolerated in humans, but they can cause some side effects. For Erlotinib, common side effects include diarrhea and skin rash, and there is a report of hand-foot syndrome (a skin reaction on the palms and soles). Axitinib can cause diarrhea, high blood pressure, fatigue, nausea, and vomiting. Monitoring and managing these side effects can help ensure the treatment is effective.678910
What makes the drug combination of Erlotinib, Axitinib, and Lenvatinib unique for cancer treatment?
This drug combination is unique because it targets multiple pathways involved in cancer growth. Erlotinib inhibits the HER1/EGFR pathway, which is crucial for tumor survival, while Axitinib and Lenvatinib target other tyrosine kinases, potentially offering a more comprehensive approach to stopping cancer cell growth compared to treatments that target a single pathway.711121314
Research Team
Sarah J Shin, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults over 18 with advanced solid tumors that have worsened after treatment or for which no standard treatment exists. They must be able to swallow pills, not have severe infections like AIDS, and should have stable vital organ functions. People with certain heart conditions, those on specific drugs that affect the trial medications, smokers, pregnant or breastfeeding women are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive erlotinib in combination with either lenvatinib or axitinib in 28-day cycles. Treatment continues as long as it is effective.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Axitinib
- Erlotinib
- Lenvatinib
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
- Renal cell carcinoma
- Advanced renal cell carcinoma
- Advanced renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor