What is the FALCON trial?

The FALCON (Fosbretabulin in Advanced Lung Oncology) trial is a randomized, multi-center, Phase 2 trial in subjects with advanced NSCLC. This trial is expected to enroll about 60 patients with NCSLC at many centers throughout the United States. Patients not previously treated with chemotherapy may be eligible to enroll in the FALCON trial.

What is involved if I participate?

In this trial patients will be randomly assigned to one of two treatment groups (arms). Because the FALCON trial is randomized, you will have a 50-50 chance (like flipping a coin) of receiving fosbretabulin. Those patients assigned to Arm 1 (approximately 30 patients) will receive the standard approved treatment of paclitaxel, carboplatin and bevacizumab, every three weeks for up to six treatment cycles. Those patients assigned to Arm 2 (approximately 30 patients) will receive the standard treatment of paclitaxel, carboplatin, bevacizumab, as well as the study drug, CA4P, every three weeks for up to six treatment cycles. The length of time you participate in the trial will depend on a number of factors such as evidence that your disease is becoming worse (i.e., increased lung/chest pain, difficulty breathing, loss of energy or evidence of tumor growth with CT scan), termination of the trial (by OXiGENE or a regulatory agency such as the FDA), a determination by your physician that you are no longer benefiting or you decide to discontinue from the trial for any reason at any time. During the course of the trial, CT scans are performed early and often. This is done regularly to check your response to CA4P.

During the trial, patients will receive close monitoring with electrocardiograms (ECG). An ECG is a simple procedure that records electrical changes in the heart in order to check heart function. ECGs are done frequently in this trial for safety reasons, as CA4P may occasionally be associated with heart abnormalities (irregularities). If you are in Arm 1 and successfully complete all six treatment cycles, with the approval of your doctor, you may continue to receive bevacizumab until your disease worsens or the trial is terminated, your physician determines you are no longer benefiting, or you choose to discontinue for any reason at any time. If you are in Arm 2 and successfully complete all six treatment cycles, with the approval of your doctor, you may continue to receive bevacizumab and CA4P until your disease worsens or the trial is terminated, your physician determines you are no longer benefiting or you choose to discontinue from the trial for any reason at any time. CT scans will be done every three months during this phase of the trial. OXiGENE reserves the right to cancel this trial at any time.

For more information, please speak with your physician.

What side effects might I experience?

During this trial, you will be carefully monitored; however, you may experience some side effects. In over 350 subjects to date, there have not been any reports of an allergic reaction to CA4P. The most common side effects observed with CA4P are tumor pain, fatigue, weakness, headache, and nausea. Some of these side effects may also be cancer-related. Occasionally, there may be a rise in blood pressure after CA4P is administered. This rise in blood pressure may require you to be treated with a medication to help lower your blood pressure.

A list of side effects as described in the drug package insert or website for the chemotherapy agents and anti-angiogenic drugs being given in the FALCON Trial are as follows:

• Carboplatin: The most common side effects (occurring greater than 30%) are low blood count (including red blood cells, white blood cells, platelets), nausea and vomiting, taste changes, hair loss, weakness, or blood test changes (abnormal magnesium levels).
• Paclitaxel: The most important side effects are allergic reactions that vary from mild to severe and may cause (depending upon severity): trouble breathing, very low blood pressure, sudden swelling, and/or hives or rash; low blood pressure, drop in heart rate, hair loss, joint and muscle pain, irritation at the injection site, low blood count (including red blood cells and white blood cells), fatigue, mouth or lip sores, numbness or tingling/burning in the extremities (hands and/or feet), upset stomach and/or diarrhea, decrease in the need to urinate, and swelling in the face or extremities (hands and/or feet).
• Bevacizumab: The most common adverse events seen in patients receiving bevacizumab with chemotherapy across all studies are weakness, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, loss of appetite, mouth sores, constipation, upper respiratory infection, nosebleeds, difficulty breathing, skin irritation, and proteinuria (a possible sign of kidney malfunction). Important safety information for bevacizumab include gastrointestinal (GI) perforation (a puncture in the stomach, small intestines, or large intestines), wound healing complications (for example, when a surgical incision has trouble healing or staying closed), and hemorrhage (a severe bleeding problem at the site of the tumor).

For more information on all possible side effects and safety information/warnings for any of the above drugs, please speak with your physician or visit the specific drug websites provided earlier on this webpage.

Where can I find a trial site?

You should first speak to your physician about the FALCON trial. You can also contact OXiGENE Inc. at 877-638-0070, or email the FALCON clinical trial support team at falcon@oxigene.com.

Click here for a list of currently open trial sites. Additional trial sites may be opened on an ongoing basis. Please visit this site regularly for updates.

Can I be reimbursed for travel expenses?

Trial participants may be eligible for reimbursement of certain out-of-pocket expenses incurred while participating in the trial. For more information, please speak with the trial coordinator at your nearest clinical trial site. Note, policies may vary from trial site and state to state depending on local regulations.

How can I participate in the FALCON trial?

First, you should speak with your physician to determine if the FALCON trial is right for you. As with any clinical trial, participants must meet certain criteria related to past and present medications, other health-related conditions, and other trial requirements in order to participate in the trial. Your doctor or nurse will review the trial criteria with you in detail; however, initial eligibility criteria include:

• Must be at least 18 years of age
• Have advanced NSCLC that cannot be treated surgically
• Have not received any prior chemotherapy for NSCLC
• No brain metastasis

For a complete list of participation criteria, please visit: http://clinicaltrials.gov/ct2/show/NCT00653939

If you or someone you know may be eligible to participate in the FALCON trial, he or she can contact Oxigene Inc. at 877-638-0070. You can also email the FALCON clinical trial support team at: falcon@oxigene.com.

Please check the clinical trial site list to see if there is a site open near you.