is it worth it to wait for a clinical trial?

Portal Forums Cancer Basics Clinical Trials and Drug Development is it worth it to wait for a clinical trial?

This topic contains 5 replies, has 3 voices, and was last updated by  Dr. Ben Creelan 2 years, 10 months ago.

Viewing 6 posts - 1 through 6 (of 6 total)
Author Posts   
Author Posts
January 20, 2015 at 12:22 am  #1268146    

kkh130

Hi 
My dad was diagnosed stage IV nsclc last year. He was doing well on tarceva for 8-9mo. However, the most recent ct scan shows progression with several new pulmonary nodules and pericardial effusion (but the primary tumor has mildly decreased in size and shape). His oncologist thinks it is time to start chemotherapy. 
I want him to take the opportunity to participate in either co-1686 or azd-9291 clinical trials because I’ve heard these two drugs has high response rate with less side effects compare to chemo.
However we are told that my dad’s new pulmonary nodules are too small (5mm) to do biopsy for t790m mutation test (the old primary tumor is stable in size 3.6cm). The doctor wants him to stay on tarceva and wait for another two months for the new tumors to grow larger. I do not know if we should start him on chemo now or wait for co1686 clinical trial (this trial requires no chemo prior to the start of the new drug). There’s only 50% for him to have the t790m acquired resistant mutation and 50% responding rate to this novel drug. Waiting for doctor appointments and biopsy results may take another two months, so that means my dad will not receive any new treatment for total up to 4 months to check if he is qualified for the clinical trial. I am afraid the tumor may grow out of control on the waiting period. I remember last year his tumor grew from 3.5cm to 7.5cm within a month after biopsy (he also had high fever at that time). I know chemo is very hard and harmful to the body and some people may not able to make it through. 

Please I need helps and advice. I don’t know what to do. I already lost my mom to liver cancer. He is only one I have.


Diagnosed in 2014 stage 4 nsclc. EGFR+ (also positive for t790m). 1 year on Tarceva, then 8 months on Rociletinib, then WBR following by 7 months on Tarcrva pulse/carboplatin/avastin/alimta, then 7 month on Tagrisso. Was diagnosed leptomeningeal metastasis Nov 2015. Now has 10cm big tumor and multiple nodules with different sizes. Most recent guardant test (Feb 2017): TP53 C277F 29.8  EGFR Exon 19 Deletion 20.1  EGFR AMP ++  MET H1112Y 0.1  MET AMP +  FGFR1 AMP ++  PIK3CA AMP +  CCNE1 AMP ++  BRAF AMP +  MYC AMP ++  Additional Alterations  BRCA1 R7C 0.3  MTOR K1197E 0.2  NF1 V1762V 0.2  MET E436K 0.1  JAK2 V617F ND  MAP2K2 E66K ND 

January 20, 2015 at 4:32 am  #1268148    
catdander forum moderator
catdander forum moderator

Normally a person who is considered to have acquired resistance is kept on the tki until a he is ready to begin new treatment with a short wash out period of a week or two. It is believed that the drug is still working on some of the cancer while other parts have grown resistant to it (most often with the t790 mutation).

I’ll ask one of our specialists who researches these tki’s to comment.

I hope your dad does well,
Janine

January 21, 2015 at 5:59 am  #1268166    

kkh130

Thank you, Janine.

Let me clarify one thing on the information I provided: his tumor grew from 3.5cm to 7.5cm while waiting for EGFR mutation results and not on any treatment at all. I don’t know and can’t predict the growth rate of the tumor cells when he is kept on tarceva. I’ve heard that the tarceva can’t cross the blood brain barrier at normal dose. So what are the common symptoms for brain met?
again, is it worth it to wait that long for a clinical trial? (1/5/14 ct scan showed progression; 1/9/14 his oncologist suggested chemo; 1/16/14 second opinion suggested to wait 2 more months for biopsy).
I also want to know what other things I should do and what symptoms I should watch out for while waiting for re-biopsy.
His condition deteriorated after biopsy last time and tumor grew in a fast rate. Is all this normal to a lung cancer patient?

Thank you very much,

Joan


Diagnosed in 2014 stage 4 nsclc. EGFR+ (also positive for t790m). 1 year on Tarceva, then 8 months on Rociletinib, then WBR following by 7 months on Tarcrva pulse/carboplatin/avastin/alimta, then 7 month on Tagrisso. Was diagnosed leptomeningeal metastasis Nov 2015. Now has 10cm big tumor and multiple nodules with different sizes. Most recent guardant test (Feb 2017): TP53 C277F 29.8  EGFR Exon 19 Deletion 20.1  EGFR AMP ++  MET H1112Y 0.1  MET AMP +  FGFR1 AMP ++  PIK3CA AMP +  CCNE1 AMP ++  BRAF AMP +  MYC AMP ++  Additional Alterations  BRCA1 R7C 0.3  MTOR K1197E 0.2  NF1 V1762V 0.2  MET E436K 0.1  JAK2 V617F ND  MAP2K2 E66K ND 

January 21, 2015 at 11:11 am  #1268180    
catdander forum moderator
catdander forum moderator

Joan,

I think you’re wise to want to keep a close eye on your dad and any new or worsening symptoms. Whether he decides to wait for enough tissue to biopsy or begin chemo it’s always important to let his onc know of changes. The good is his cancer is being mostly controlled with tarceva, enough so that there isn’t enough tumor burden to even biopsy. If his cancer begins to move rapidly like before tarceva many specialists believe it can be caught early enough to begin standard treatment without needing to wait on a biopsy. That’s a personal call to be made among the people personally involved.

Dr. West has this to say about waiting, “Unless we know that the cancer is progressing at an unusually rapid rate, it’s very typically to take 2-3 weeks, and sometimes more, to decide on and plan for a next line of therapy. There is rarely any urgency, especially when a patient has had issues with low blood counts.” http://cancergrace.org/topic/waiting-period-before-new-treatment-started/#post-1268132

I understand it’s an impossible perfect decision making process. I think anyone here would say it’s the most stressful of times. Once the decision is made stress levels decrease and as a loved one and caregiver I believe the choice made is the right one (even the one I least like I can justify it’s possible benefits).

I’ll make sure we have an oncs input by the end of the day. Much luck to you and your dad, he’s lucky to have you.

Janine

January 21, 2015 at 11:39 am  #1268181    
catdander forum moderator
catdander forum moderator

About brain mets
Symptoms depend on where the met is. They can include headache, change in focus both in the eyes and thought process, balance, muscle control, speech. Anything new or worrisome should be reason to call the office. I know it’s almost useless to say but don’t assume the worst, most of these things can easily be stress related also.

All the best for you and your dad,
Janine

January 21, 2015 at 12:44 pm  #1268182    

Dr. Ben Creelan

I think if he is becoming symptomatic (more tired, weight loss, shortness of breath), then it may be smart to start carboplatin/Alimta chemotherapy. We like clinical trials, but no one should ‘hang their hat’ on a clinical trial, because it takes a long time to enroll and eligibility is never guaranteed.
If he is doing ok on the Tarceva, then it seems reasonable to wait it out and see what happens with the nodules in 6 – 8 weeks. The new drugs certainly are promising for T790M but they can always be saved for another line of treatment. Remember that T790M can often be tested from cancerous pleural or pericardial fluid too.

It is impossible to speculate about growth rates of tumors. As long as he is on the Tarceva, the tumor growth is probably being suppressed a bit.

Viewing 6 posts - 1 through 6 (of 6 total)

You must be logged in to reply to this topic.