Trials Can Be a Trial

The last week has been a roller-coaster ride for us. The chemo combination that Karen’s been on for the last six months is at the end of its usefulness to her. It’s reduced the tumor size but is becoming too toxic for her. It’s beaten back the cancer a bit, but also suppressed her immune system and made her ill.

Wednesday we received the results from the CT scan and most recent round of bloodwork. The tumors have reduced in size, but not gone away. Karen’s oncologist has indicated that remission is not easy to define, but characterizes it as reducing the tumors significantly. It’s generally accepted that if the tumors get so small they can’t be seen on a CT scan, then you’re in remission. Although the sizes shrunk for Karen, the ones that they are tracking have reduced around 25% with her larger tumors still a bit larger than golf ball, but smaller than a lemon.

This news is encouraging and disappointing at the same time. We obviously wanted results that indicated she was in remission, or much closer than she is. We’re glad that the chemo slowed the progression, and visibly reversed it, because this is not the case with some patients. In that aspect, we’re glad. But everybody hoped for remission.

This news has been followed with some very frustrating events. Over the last few months the chemo has been difficult for Karen, but predictable. For the most part we became used to the process and knew what to expect each week from the treatment. It was lots of nasty stuff, but mostly predictable. Now we’re traveling into the unknown again, and it’s more complex than before. The doc feels that a trial is the best option for Karen, but there are challenges to making that happen for her.

Trials have qualifications, and it seems that Karen has more complications than most patients. The Scientific Method requires that as many unknown variables be removed as possible when you’re testing a theory. In the case of a trial they are theorizing that the medication helps a specific condition. In a perfect world, a trial would be performed on an array of people who all have the same characteristics. If not, then it’s too hard to interpret the results.

For example, some medications might be suspected of cause blood clots, so they can’t allow people with clotting disorders (like Karen) into the trial, because if the patient has a clot during the trial they can’t be sure what caused it. I’m sure you’ve seen the side effects listed for medications on commercials. The funniest ones are medications that list side effects the same as what they are trying to fix. For example, antacids causing upset stomach. Trials try to avoid letting patients participate if there is a greater possibility they will provide information that can’t be interpreted reliably. Some trials have very strict criteria, so they have a better understanding of what the results mean.

We’ve already seen that first hand. After the results on Wednesday the doc discussed a trial they are holding at the Zangmeister Center. He had already been working to pre-qualifying Karen and we spoke at length about the trial and other conventional treatments. Karen decided she wanted into the trial as the next step. Roller coaster up, down, and now up again. But you can see where this is going.

We received a call yesterday indicating she was not accepted.

When I mentioned the challenges for meeting qualifications I also mentioned some complications for Karen. The first involves the troubles classifying the cancer in the first place. She needs a trial intended to treat a gynecological cancer (ovaries, fallopian tubes, peritoneal). As a qualification, they use biopsy pathology to confirm the diagnosis, but her pathology reports did not reveal the type of cancer conclusively. Her cancer was diagnosed with genetic testing and empirical data. So, she does not automatically qualify for trials that concentrate on her type of cancer. Responsible parties need convinced first.

Other important complications for Karen are related to her bleeding disorder. She has antiphospholipid antibody syndrome, which is a condition where she clots naturally. Because of this she has had serious blood clots (pulmonary embolism and deep vein thrombosis) and takes a medication to thin her blood. The trouble for trial organizers is that she has a serious medical event in her past that makes her more susceptible for a repeat event, and to prevent a repeat event she takes a medication that may (or may not) interact with the drug they want to test. [insert scream here]

Karen is scheduled to start a more conventional chemo treatment next week but we’re going to do some research about other trials. Initial research didn’t find anything applicable at the James or the Zangmeister Center, but we hope to speak with an oncologist at the James to see if she knows of something coming up, or has other ideas about the next treatments. We’re also looking for trials at centers further away, such as the Cleveland Clinic. Hell, I’d take her to the moon for a cure.

As we look for possible treatment further away, we are also weighing in the benefit of being treated near home, even if it’s with a more conventional medication. She’s comfortable, secluded, and when possible we keep the external stressors low. Karen and I have worked hard to provide a lifestyle we cherish and are surrounded by friends and family we cherish just as much. We’re concerned that long drives or staying in unfamiliar surroundings with little support would be a detriment. So, we’ll be weighing this as well.

We have guests visiting this weekend who have also had a really tough week, so we’re going to do a little consoling this weekend. I’ll give an update next week or weekend to share anything new.