6 posts tagged “clinical trial”
"I can't cure you."
The words tumbled out of his mouth, in opposition to the more hopeful sentiments of past visits, where his goal was to get me to scuba dive again, "Even if it's just a matter of putting the gear on, going down, and coming back up." Dr. Simmons was a little more guarded than usual, possibly because our visit was interrupted by another Taxol patient reaction.
I've been coughing, with shortness of breath, for 9 weeks. My scan was "good" though, so the complaint fell by the wayside. It's escalated, and I mentioned the similarity of my walk in SF last week to the experiences I had prior to diagnosis. I was worried. It's a tough situation because of all the tree pollen in the air. I have infamous allergies to trees (sad, they're one of my favorite things), but they've always manifested as hay fever. I've never been a "cougher" until this illness struck.
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I began that post on the 20th of April but couldn't finish it. Too many distractions, my brother was up for a week, then I had my bone treatment which was followed by what I can only guess was a horrendous incidence of food poisoning. I just wasn't feeling it (the post). And I'm still not, but I had my 6-week scan today, and my next onco visit/chemo treatment is on the 9th, so this needs legs.
April 18th's visit was markedly different from past appointments, where I was doing well and we all sort of breathed a sigh of relief until next time. The doc listened to my lungs and said they sounded fine. When I asked about traveling to Hawaii, though...he was reserved. In the past he'd said, "Why can't you?", when asked. This time he had his assistant place the oxygen sensor (?) on my finger and walk me around the corridors a couple of times, ostensibly to test lung function. The results were alarming. My oxygen level dropped to 83 (below 88 is unacceptable). The nurse was in disbelief. She thought perhaps the finger thing had slipped off or I really was on the verge of passing out. We did it again, at a slower pace. My pulse shot to 101, but my O2 level stayed at 99. Still, it was cause for concern. I was told I could fly to Reno or Oregon , but New York was not recommended. Therefore, flying to Hawaii is out. At least for now.
The moral of the story is, don't put off till tomorrow what you could've done yesterday, right after chemo. Berating myself for going to NY instead of Hawaii at Christmas accomplishes nothing, but I'll probably be doing that in my sleep.
The clinical trial nurse will be on vacation next week. I usually visit
with her when she replenishes my study drug (the placebo which is supposed to
be Tarceva). I've told her of the cough. "Well, since you're
symptomatic, we may have to shift gears even if the scan is ok." In
not so many words, this means "end of trial". Any treatment
outside the protocol ends the clinical trial.
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So tonight I caught Ted Koppel's documentary, Living With Cancer, on the Discovery Channel. His best friend Leroy Sievers had lung cancer, and had undergone initial chemotherapy. During a 3-week break, the cancer metastacized to his spine. Not till the end of the show do you find he had transferred to John Hopkins for treatment after this occured.
The show follows Leroy's path through second-line treatment. He begins a 9-cycle run of chemo, and at some point, one of the 3 lung tumors grows by 50%. I wish they would've mentioned what he received, but maybe that would cause an uproar among the masses not receiving said combinations. Surprisingly, nothing about possible clinical trials is ever mentioned. Also, nothing about the type of lung cancer he has, and whether it was caused by smoking or not. Maybe it doesn't matter, but to us non-smokers, it kind of does. Lung cancer is severely underfunded due to the stigma that only smokers or folks exposed to asbestos get it. Lung cancer deaths are 4 times greater than the next largest killer---colorectal cancer, but it's never divided into smoker/nonsmoker deaths. Research funding is about a quarter of what it is for breast cancer. And no one's doing fundraisers or marathons for lung cancer, mostly due to the stigma.
Now, this is vague---but now that chemo is no longer a treatment option, the oncologist (a "fellow", or oncology resident) decides to radiate the lesion on Leroy's spine (is this a quality of life decision?), thus leaving him with "just" the 3 lung tumors. He is then told to wrap it up---they can't do anymore for him. It's time to get his legal papers in order. Again, more vagueness---all of a sudden, this radiation oncologist appears and offers to use a fairly new procedure on him: Radiofrequency ablation. It's an outpatient procedure, and has some risks, not the least of which is the lack of clinical trials proving the efficacy of the method. They stick the needle in his tumors, send electricity through---the tumor is fried to a crisp. It's done, no complications. This film segment is fairly short, including Leroy's interview in the recovery room. How did Dr. Georgiatus (the radiation oncologist) get into the picture? Did Leroy do lots of last ditch attempts to find other treatments? Did one of his many connections come through with the name of the mad scientist in the basement? Leroy's oncologist seems almost at odds with the whole thing.
Suddenly, at 17 months after diagnosis, Leroy is cancer-free. Not cured, Leroy is careful to say. But scans are clean, for now. At a commercial break, I google John Hopkins and Radiofrequency Ablation. I get nothing. There's info about it from the National Institutes of Health, but nothing about it at John Hopkins. The show then goes live with a townhall meeting set-up, and there's Leroy with Elizabeth Edwards and Lance Armstrong (whose now-legendary story prefaces the documentary). Questions are fielded, but not much more new information. Lots of encouragement to blog.
I watched the whole cotton-pickin' 3 hours. The show is about feelings and not as informative as I
thought it might be. It's a personal piece, I guess. Much of what
Leroy went through and feels is on the mark and spot on, so it deserves at least a "B". However, for totally vague
information and lack of discussion of treatment-related issues, it's going down to a C+ (for being made). Not much solid
info about "living with cancer". Leroy never discussed how he
overcame his nausea or his bouts of sadness or how his treatment decisions were limited by being unresectable, etc, but I think he says it's all in his blog.
His girlfriend(?) speaks up at the end, but prior to that, one doesn't even realize she exists. I believe the show replays on the 7th...check your
local Discovery Channel listings.
Edit: A counterpoint to the documentary is Jonathan Alter's article in the April 9 issue of Newsweek, also called "Living with Cancer." Again, it includes an interview with Elizabeth Edwards and a piece with Lance Armstrong. It contains a bit more information than the show, but the article basically concedes that this is a good moment for media attention. I note a lack of opinion on all sides as to the government's diversion of funds from research to the war in Iraq.
And Doc Simmons still firmly believes I'm on the placebo. He gave me a card to a restaurant he recommends highly. Angeline's Louisiana Kitchen is over on Shattuck---Berkeley northside I think. Like I said, I love that we talk about other things besides the tumor that's now 4 cm. It was 7cm back in August before I started chemo. No change to the bone lesions, and no new ones. He's getting really impatient. He did refer me to a podiatrist for my sore left instep. Sounds like I fractured it long ago and ignored it. Now there's something like a bone spur on my instep. Anyway, nothing about the cough. Maybe it's allergies?
My confusion has to do with the size of the large tumor. On Valentine's Day, Rosalie (the clinical trial nurse) said the tumor had shrunk to 5.2 cm. I just read on the report that at the last scan, it was 4.1cm. Is she confusing me with someone else? I'd rather have 4 cm, of course, but this time, she said, "Your scan looked great!" I suppose I could read the report from February, to see what's what, but the current report says quite clearly, in parenthesis, that the previous measurement was 4.1cm.
Anyway, I spent a couple of hours with my friend Grace on Friday, and part of it was spent sniffing perfumes at Bloomingdale's. I can't say for sure, but I believe this was the cause of the migraine that set in shortly after, which plagued me all weekend. My sinuses opened up this morning, allowing me a couple of hours of sleep, finally.
Note to self: no more perfume sampling. This will also prevent me from spying any more $1600 handbags I may try to justify buying. (The justification is also the impediment: I'm dying therefore I should enjoy it; I'm dying, so why should I acquire more possessions?) (There's the opposite argument, which is, "Buy and enjoy if that's what you feel. You don't know WHEN you'll die...etc.) (This is an interminable argument)
As for other expensive things...I want to make plans to travel, but it's difficult to make last minute plans, and making long-term plans is sketchy, as I can't predict where I'll be in, say, 3 months. Aaarrrggghhh.
There's a new travel show based on the book by the same name, but it really ought to be called, "1000 places to see before you die---in 6 months or less."
I should probably give these cancer updates a title theme. I was thinking along the lines of Star Wars. I have to give this more thought, although more and more I see my disease as the Death Star and my white cells as the Rebel Forces. As Yoda would say, "Do. Or do Not. There is no try." Yoda told Luke he failed because he didn't believe.
So I've been watching alot of Star Wars on HBO.
Well, the Force is with me, dammit. A friend who shares the same oncologist said his comment about me was, "She's tough as dirt!" --- or something like that. I'll take that as a compliment, considering he believes it to be force of will, rather than a physical fact, my ongoing well-being.
I am not so diligent as I should be, however, with the things I think are ultimately most beneficial: exercise, a restrained diet, meditation, guided imagery, prayer, alternative aids like massage and acupuncture. I truly believe these are the keys to beating this thing, or at least making the short-term goal of five years survival. I say five years, because a mere 15% of all lung cancer patients - total statistics, which mean including those cured by surgical resection - live beyond five years. If I have to live with this thing, fine, but let me live longer, with a good quality of life!
Anyway, this visit was uneventful. They're basically waiting for the next CT scan to see if there's any movement either way. I would like greater shrinkage, but this means continued waiting on their part, as they can't unblind the study (clinical trial) unless there's disease progression.
Like I said, if I can will this thing to shrink without the aid of pharmaceuticals, more power to me.
I did read that a study on higher doses of Avastin (Bevacizumab, which is one of the study drugs I'm on) showed progression-free survival was 30 months as compared to 17 months for those treated with chemo agents alone (without the addition of Avastin to the regimen). That's a long time compared to initial studies showing additional survival time was only 2 months. I'll take 2 years, thank you.
I am eternally grateful for the lack of side effects up to this point. I feel pretty good. Praise the Lord, knock on wood, kiss the lucky charm, and everything else. I still get tired when I do alot (my alot is not the same as your alot). But my hair's grown back and I like it. Reminds me of the '80's look. Now if I could just lose the 15 lbs. I've gained since November, that would be great.
That's what the hubby says and it's kept him on track all these years (even though he doesn't do anything slow at all).
I had my usual doc visit + chemo on Valentine's Day, with my oncologist running so late that I only got a 7- minute visit before being dragged off to infusion before closing time. This was also my latest CT scan review.
He said he was "concerned---not apprehensive and not fearful, but concerned". Something about my body being made up kind of weird, not quite right, but he can't figure it out. I started the study (clinical trial) on Thanksgiving, and patience isn't his strong point---things are receding, but for my age and health, we should be seeing larger results, faster. He thinks I'm receiving the placebo instead of the study drug, due to my lack of side effects. He's ancy and will unblind the study the minute anything starts happening. But we have to squeeze every drop out of this treatment right now. That was his 7-minute assessment.
Ok.
During the infusion, the clinical trial nurse came over and gave me another perspective. She explained that the large tumor (lung) had decreased by .4 cm and the bone lesions were more sclerotic (healing, scar tissue). The way the radiology report was written indicated a greater number, which prompted her to call. The radiologist said there were no new lesions, but that more of the lesions were sclerotic.
That said, she remarked that statistically I was doing far and away much better than any expectations (especially if I was receiving the placebo rather than the study drug), and the key seemed to be having fun.
So, I'm supposed to have more fun...hang out with friends, laugh, go to museums and concerts, get massages, sleep in, and not worry about the thousand and one things I worry about, like work, money, my aging parents. I'm thankful for every bit of fun I've managed since my diagnosis, but it's definitely on borrowed time.
I am relieved, buoyed by yet another "stable" scan. I'm trying to be more diligent about exercise and guided imagery, meditation and diet (I've gained 14 pounds in 2 months---that can't be normal). I have something like a rash on my scalp, so I'm not entirely convinced I've been taking sugar pills since Thanksgiving. But even so, I want to believe in the mind's power to heal. It's the final frontier, and I've read many accounts of incurable patients going into remission. It doesn't happen overnight, but if my tumor shrank by .4 cm/6 weeks, I may be well in a year and a half. I'll take even more modest progress, if it means I'll live that much longer...heck, I want to grow old!
Of course it's not that simple, but simple goals are best: shrinkage of main tumor and good quality of life. I would be content with success in those two areas. To that end, I've been encouraged to join a gym and push my exercise limits (the physical therapist says it'll take care of the pain/insomnia/weight gain issues). Now if I could just address the thinning hair (ironic that I, previously of the big-hair contingent, should say that) and the vanity issues, which I can't believe are plaguing me at this juncture. It's a media disease, I'm certain.
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I received jewelry for Valentine's Day, for the first time ever. Even though it's a "Hallmark Holiday", it's nice to exchange vows of love in a formal way. In years past we paid it no mind, and Mike absolutely loathes cards, so we don't use that gesture. We are exactly opposite---I'm relatively unmaterialistic and love a written sentiment, and he likes stuff---Swedish fish and good candy, small expensive gadgets, large expensive boats, expensive hobbies, expensive...Hmm. Well, he might have to "settle" for his wife living longer for some holidays to come ;)
The evening seascape is dazzling. The bay is a shocking blue with glints of titanium, overlayed at the edges with sandbars of molten gold and black sand lace. The necklace of San Francisco's glittering silhouette pierces sea and sky, chained to the horizon by the trail of shimmering cities across the bay. The sky is its own bright blue edged in a peachy glow. It's a post-modern Dutch seascape missing the incandescent sails of grand vessels.
With each exquisite Alameda sunset, I am renewed. My heart wanders to other places, to maple forests and tall mountains, but as I round the bend from either direction, my heart jumps, and I'm home again, in dear old Alameda. Here comes the full moon, ready to blaze the nightscape over the Bay. It was a warm day, the tide is far, far out---someone ought to build a fire and throw a party on the beach. There's little wind. It's a balmy eve. Alas, the sidewalks are rolled back early, old village style. I spot 2 fish taller than myself hanging off my neighbor's pergola. I could be back in sleepy northern San Diego County.
I don't know why the weather influences me so. I reveled in my pine scented commute from Walnut Creek today, no doubt drawn out by last week's moisture. I am a girl of the West through and through, loving the arid warmth of these regions, but I will concede, we do need the moisture. It's a different type of good weather, and the hubby needs more of the seasons. (He's an east coaster and really misses the seasons. He threatens a move to more varied climes. I counter with his fondness for scuba diving and a logical choice of more tropical locales.)
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On the cancer front, I had my final infusion of Gemzar today, marking the completion of 4 cycles of the Carboplatin (Paraplatin)/Avastin (Bevacizumab)/Taxotere (Docetaxel)(2 cycles and then allergic reaction) and Gemzar (Gemcitabine)(the last 2 cycles) combo I was to receive prior to starting the clinical trial (Nov. 20th). Gemzar was a medication initially developed for pancreatic cancer, so it's supposed to be good, but for what I have, doctors like Taxotere and Taxol. But I'm allergic to various and sundry trees, and those two are derived from a European Yew tree that grows in the Pacific Northwest. It's no good if it cuts off your breathing, so I'm just glad they found something in the top 3 that I'm not allergic to! I've also been started on ProCrit (or Epogen), which is a hemoglobin booster. It helps your body generate red blood cells, which provide your oxygen. It's ironically one of the performance enhancers tested for in contests such as the Olympics and World Championships.
Doesn't it make you wonder how my liver and kidneys are taking all this?
I am relieved yet apprehensive. The clinical trial I'll be on is a double blind study involving 1 or maybe 2 chemo agents. If I receive the placebo, I'll only be receiving one agent that theoretically prevents tumor(s) from creating new blood vessels to feed (anti-angiogenic---there's a more technical description---some of you are familiar; those who aren't, I'll tell ya if ya really wanna know). It's like starving a vampire by keeping it from regenerating bicuspids. I pray I am randomized to receive the study drug and not the placebo. Both drugs are manufactured by Genentech, which has a plant in the Bay Area, and are trademark-named Avastin and Tarceva (Erlotinib). Very, very expensive if you aren't insured ($8800/month and $3300/month, respectively). But will it be enough? Initial studies in Asia showed promising response rates among Asian women. But this does me no good if I get the placebo! Sigh.
I'm nervous. An older woman (60's or 70's?) across from me today had 16 cycles of Taxol (paclitaxel) (the first drug I was allergic to) 3 years ago. Now she's back and will be receiving something like 12 cycles. It makes me question how aggressive my treatment is. Should I be looking for something else, somewhere else? She's still kicking...!
I worked on my Nano project a little, read one of the 3 newspapers I'm now receiving, and worried about a side effect of my IV-administered bone medication (Aredia, a biphosphonate)---osteonecrosis of the jaw (ONJ), or Dead Jaw, and of the hip. More about that in another blog. As if I didn't have enough to worry about.
I feel like turning into a work-out freak again. This is my full-time job---reading about healing, exercising, doing relaxation/meditation/visualization exercises, disinfecting my home and being the housekeeper I never was, restraining myself from the pumpkin muffins my sister brought over (I come from a food-oriented society that values yumminess (aka sweet snacks) as a primary facet of only living once), trying to cook creatively without using anything containing fructose, sucrose, glucose, honey (I think I can still do the pork chops marinated in orange juice with fresh thyme, or the herbed pork loin with sour cherry sauce, but not the maple-glazed pork chops on baked apples)...
(Oh damn, I don't think I'm supposed to eat pork?)
(But I love dry fried ribs, aka salt and pepper short ribs...and Kalbi)
(Is my cultural identity that wrapped up with pork? Is Rumaki out?)
Aaaaaarrrrgggghhhhhh....as I was saying, my full-time job is to GET WELL. THAT is more important than FOOD!
Oh yes, and a couple of other activities to be added to the above job description---be a Mom to my Siamese cat, be a loving wife (this used to say Wife who takes care of business as 2nd job), pray to my God to comfort me and bless the world, and above all else, to myself be true. I feel like something's been over my head for a very long time.
How can I not worry/be happy when one of my long-term meds could cause me to have a total hip replacement or excruciating, incurable, smelly disfigurement of my jaw/teeth? Is kissing/eating/smiling out, and the hip? Well that's another ball game altogether. Do I cower out of fear or torture myself by reading more scientific papers or launch into action and try to find a dental oncologist...or just try not to think about it and take Ativan (just call me drugstore cowgirl) ?
I would appreciate recommendations for good dentists in the East San Francisco Bay Area from anyone willing to comment (I still have your recommendation, Judge Gee). My holistic dentist (a former acupuncturist and Army dentist) developed cancer late last year and was forced into early retirement (Dr. Rothman).
Thanks for any pearls of wisdom regarding this topic.
I've moved past the point of thinking about my "condition" all the time, although it definitely informs my entire life right now. I have one "large" chemo left, on 10/25 and 11/01, then the clinical trial starts 11/15. This "large" chemo will be Cycle 4, which is all they'll be giving me of this particular cocktail. I'm enrolled in a clinical trial until "disease progression, unacceptable toxicity, or for two years or voluntary termination." I think the voluntary termination means *Cured*, but they never say that to Stage IV folks like me.
In other words, it would be a miracle.
If you don't already know, I plan for that miracle (what've I got to lose?). And if not, then I'd like to continue living well until *Morty* (see the movie "Click") comes for me. I have things to do, places to go, people to see until then, so I'm not ready for ya, Morty.
So the answer is, I feel generally OK.
As for the novel I hope to write for NaNoWriMo...well, maybe it'll excise some of these demons I've been hosting for too long.
If you gaze for long into an abyss, the abyss gazes also into you.---Nietzsche
