Anyone on clinical trial: Nexavar/Sutent/Placebo?

Hi everyone.  I had a right radical nephrectomy on 7/2/09.  Cancer was stage 3a because it had come out of the kidney capsule a little bit. I got 3 oncologists opinions and all 3 said I need to do this clinical trial.  I just wanted to know if anyone else was in this trial and how do you feel?  I just started regimen of pills about 5 days ago, and so far just a little upset stomach and quite a bit of fatigue.  I was started on lower doses since I am underweight.  Of course I don't know which drug I am on or I could just be getting a placebo, but I can definitely feel a lot more fatigue so I think I must be on one of the two drugs.  Just curious about others out there in this clinical trial.  Take care!

My husband (who is 55) was diagnosed with Stage 4 Advanced Renal Cell Carcinoma and had his Right Kidney removed in April 2009, along with a tumor that had grown from 6 inches to the size of a football weighing nearly 10 pounds in just 6 weeks. His surgery and recovery went beautifully.

It has been 6 months since my husband's surgery. He is now in his 4th round of targeted treatment (Sutent 50 mg) and is doing fantastic. Prior to surgery his weight had dropped to 158 pounds (he is a 6 ft tall man) and he is now back to 228. We, of course, were told about the Clinical Trial option but chose to take an approved treatment from the get go!

The tumors had spread throughout his lungs prior to surgery and they have almost completely resolved. New scans will be done in late October and we are fully expecting to hear that no tumors remain.

Also, if you aren't already seeing a Doctor whose specialty is Urologic Oncology, you should, since many regular Urologists don't stay as up to date as possible on the latest treatments for Renal Cell Carcinoma. From your post, it's pretty clear that you don't have a doctor who knows much about RCC because Sutent is no longer a trial drug (nor are any of the other drugs you mentioned).

Also, when we talked with our doctor about the possibility of having to take a lower dose of Sutent (as we had read that some were taking), he said, "Why would we want to give you a lower dose that is less effective? If this doesn't work, or if you have side-effects that can't be managed, we'll move on to something else that will work!"

From the time of my husband's diagnosis, until the date he began taking the 50mg Sutent, the trials had started for another medication, Afinitor, and that is now the approved first line of treatment for Advanced RCC.

Like many, we felt Cancer was a death sentence. We have been happy to discover that, with the right plan, this isn't necessarily the case.

 

On 10/1/2009 numbr1nana wrote:

My husband (who is 55) was diagnosed with Stage 4 Advanced Renal Cell Carcinoma and had his Right Kidney removed in April 2009, along with a tumor that had grown from 6 inches to the size of a football weighing nearly 10 pounds in just 6 weeks. His surgery and recovery went beautifully.

It has been 6 months since my husband's surgery. He is now in his 4th round of targeted treatment (Sutent 50 mg) and is doing fantastic. Prior to surgery his weight had dropped to 158 pounds (he is a 6 ft tall man) and he is now back to 228. We, of course, were told about the Clinical Trial option but chose to take an approved treatment from the get go!

The tumors had spread throughout his lungs prior to surgery and they have almost completely resolved. New scans will be done in late October and we are fully expecting to hear that no tumors remain.

Also, if you aren't already seeing a Doctor whose specialty is Urologic Oncology, you should, since many regular Urologists don't stay as up to date as possible on the latest treatments for Renal Cell Carcinoma. From your post, it's pretty clear that you don't have a doctor who knows much about RCC because Sutent is no longer a trial drug (nor are any of the other drugs you mentioned).

Also, when we talked with our doctor about the possibility of having to take a lower dose of Sutent (as we had read that some were taking), he said, "Why would we want to give you a lower dose that is less effective? If this doesn't work, or if you have side-effects that can't be managed, we'll move on to something else that will work!"

From the time of my husband's diagnosis, until the date he began taking the 50mg Sutent, the trials had started for another medication, Afinitor, and that is now the approved first line of treatment for Advanced RCC.

Like many, we felt Cancer was a death sentence. We have been happy to discover that, with the right plan, this isn't necessarily the case.

 

I am glad to hear that your husband is doing well.  I will keep him and your family in my prayers.  I had to opt for the clinical trial as my stage was 3a and not stage 4.  They don't just give the drugs to people with stage 3a, you have to do the clinical trial to get them. 

I do have a great oncologist and got 3 opinions before I decided on doing the trial. 

How did he feel on the sutent?  I am on my 9th day and already have slight rashes on both hands and feet, extreme fatique by afternoon and slight nausea in evening.  I was started on a lower dose that will escalate in 5 weeks I believe.

From the beginning, we were careful to keep my husband on a schedule with his medication (taken the same time and in the same manner every day). At the same time each day he would, eat his breakfast and take an anti-nausea pill. Exactly 20 minutes later, he would take his 50 mg Sutent. He also ate lunch and dinner at the same time every day.

Also, I might add that he was not on any other medications and we were careful not to take anything that might react with the Sutent.

Initially he was very weak (due to his extreme anemia from blood loss prior to surgery - the tumor was draining him), but he has grown much stronger in the passing months. He has experienced all of the common side effects but none have been severe nor debilitating. The only thing we have noticed is that, with each cycle he takes, the side effects start earlier and take a little longer to subside during the 2 weeks he is off of the medication.

I still don't understand why the doctors are doing clinical trials on Nexavar and Sutent. Those have been approved for quite some time. Back in May, had my husband elected to go into a trial, we would have had to travel to Texas (MD Anderson) and gone into a trial for the next drug they were testing, Afinitor, which we've been told has now been approved.

In fact, when we opted out of the Trials, the insurance wouldn't approve any treatment other than the 1st Line of approved treatment, which was no longer Nexavar but Sutent.

I've heard good things about Nexavar and know first hand about the Sutent, so either of them is a good option.

OOPS...I meant to type "exactly 30 minutes later"