Started Regorafenib !

[pollo65]

Karmel, thank you for going boldly where none of the rest of us have gone. How does it feel to be a pioneer? Hope there are few side effects and it works magic for you ( I still believe in magic)
pollo 65

[abuttigi]

Yay KarMel! So happy you got this new drug and that the side effects aren't too terrible for you! I hope it works miracles those nasty little buggers of yours... I'll be praying!

[Patricia Ann]

KarMel, You Go Girl!!! I talked to someone at Bayer yesterday about getting into the regorafenib study at the Mayo Clinic in Minn. (Closest one for me) She told me they did not have the drug yet and did not know when they will be getting it. So she gave me a service request number and a phone number to call every few days to check on the status of its release. She also said Ann Arbor’s study was full, so I’m glad you were accepted in time. I asked her how you pronounce regorafenib since I always stumble over the word. She said to say it like “reg or off in eb”. I still stumble trying to say it. I like many people on this board have run out of options so I know a lot of us will be anxious to hear how you are doing. My onc seemed very excited about this drug so I pray that the side effects aren’t too harsh for you and that it works miracles. My best wishes to you. May God bless and watch over you.

We all look forward to hearing from you and I also am keeping my fingers, toes, eyes, etc. etc. crossed!
Thank you KarMel – God Bless!

Patti

[gep]

We're all rooting for you and sending positive vibes.
Gloria

[MJShoe]

Congratulations KarMel on starting Regorafenib. I have been accepted into two studies -- one for Dovitinib and one for Regorafenib. I have to make a decision (like TODAY!) as to which one to choose. I'm getting a lot of vague responses from the doctors. I want to take the one that holds the most promise for my health. Does anyone have any experience or information regarding Dovitinib vs. Regorafenib?

[RixInPhx]

I have been accepted into two studies -- one for Dovitinib and one for Regorafenib.
I want to take the one that holds the most promise for my health. Does anyone have any experience or information regarding Dovitinib vs. Regorafenib?

What can you tell us about YOUR disease: Staging, surgery, chemo (rad?) thus far, progression, present condition?
When diagnosed?
* * *
Regorafenib by Bayer has conclusively proven its effectiveness in combating Colorectal cancer.
It's no longer really a 'trial' though you DO have to 'qualify'; it's actually an 'Expanded Access' program prior to expected FDA approval.
I will join this study or drug, if/when my current regimen becomes ineffective.

Dovitinib is being investigarted by several companies and groups, trying it in 21 separate studies including renal, breast, lung, gastrointestinal (stomach and colorectal) and other cancers.
These are true 'trials' to see IF it is effective against most of the major cancers.
Personally, I would avoid it unless it were my last possible choice.

Just my personal opinion based on about 30 minutes of surfing the net for Dovitinib.

HTH, Rick

[MJShoe]

Hi, thanks for your response and the information you provided. I really appreciate it. As for me:

1989: diagnosed with colon cancer (Stage I) at age 36. I had a colon resection but no other treatment was deemed necessary.

1990: colon cancer returned (Stage 1). I had another colon resection but again no other treatment was deemed necessary.

8/2006: developed liver failure. This was incorrectly diagnosed as a blockage. Had an ERCP and was sent on my way.

12/2006: diagnosed with Stage III breast cancer. Did 4-1/2 months of chemo, followed by lumpectomy, followed by 8 weeks of radiation.

7/2007: diagnosed with Stage IV colon cancer. This constitutes a 17-year metastases! The doctors couldn't believe it but it's been tested and retested by all sorts of methods and it appears to be from my original cancer in 1989. This time, the colon was clean but lesions found in liver. Also had a mass on the pancreas.

7/2008: colon cancer spread to lungs as well.

Since 7/2007 I have had every recommended chemotherapy including FolFox, Folfiri, Erbitux, Avastin, Xeloda, 5FU, Irinotecan. None of these drugs have ever shrunk any of my tumors. They continue to slowly grow whether I'm on chemo or off of it at the time. Surgery was not recommended, except by one doctor who wanted to remove one lung and parts of the other. I declined based on other medical advice. RFA was also not recommended. There are too many lesions to tackle with any method other than chemo, apparently.

last December (12/2011) I was taken off of all chemo as it wasn't working and was making me ill. In March of this year it was recommended that I find a clinical trial but another bout of liver failure followed by a month of bronchitis and a week's vacation interfered. At first all I was offered was the clinical trial of Dovitinib. That particular trial was not to determine efficacy but solely to determine if the drug can be made as effectively in pill form as in the current capsule form. Then I found out about the expanded access study for Regorafenib and made the decision today to pursue acceptance into that study. Hopefully I'll be accepted and will do well on the drug. I will have to make a 5-1/2 hour drive every week to the study site but am willing to do it.

I am not done fighting yet!

[RixInPhx]

*Cliff’s Notes*: There was an exclusion in the earlier trials for prior treatment with Irinotecan, but that exclusion has been lifted from the Expanded Access program now in effect.

OK, here’s the deal about IRINOTECAN:

In the original trials, including a Phase II efficacy trial as late as this spring (’12), patient’s prior treatment of Irinotecan, or more than one prior regimen of FolFOX, was exclusionary from the trials.
This spring trial consisted of Folfiri + Regorafenib in Arm A, and Folfiri + placebo in Arm B.
I think this is the trial that was stopped because the Regorafenib was showing such great success.
See: http://clinicaltrials.gov/ct2/show/NCT01298570

Here are the current eligibility criteria for the present Expanded Access program:
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
• Male or female subjects 18 years of age
• Life expectancy of at least 3 months
• Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
• Subjects with metastatic colorectal cancer (Stage IV)
• Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
• ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
• Adequate bone marrow, liver and renal function
• Women of childbearing potential and men must agree to use adequate contraception
Exclusion Criteria:
• Prior treatment with regorafenib
• Congestive heart failure >/= New York Heart Association (NYHA) class 2
• Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
• Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
• Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours)
• Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity </= Grade 2
Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during

See: http://clinicaltrials.gov/ct2/show/NCT01538680
* * * *

Summary: There was an exclusion in the earlier trials for prior treatment with Irinotecan, but that exclusion has been lifted from the Expanded Access program now in effect.

HTH, Rick

[Ivona]

this drug sounds promising....let's all hope so!

good luck with your trial...

http://www.medicalnewstoday.com/articles/240536.php

[NedPlease]

Thanks, Rick. You are an incredible resource on this forum.

[RixInPhx]

Wow, MJShoe, you've been all over the map for 20+ years!!

Sorry I didn't see your response earlier, didn't realize you sneaked it in between my 2 posts.

Since your mets are CRC-based, it sounds like Regorafenib with its demonstrated effectiveness against CRC is appropriate.

Best of luck, and please keep us informed!
-Rick

[live2jett]

KarMel...Ditto to all the other post. Proud of you:)

[RixInPhx]

Thanks, Rick. You are an incredible resource on this forum.

Thanks, I try to contribute as much as I can.
I've gotten so much information and support that I have an actual ned to contribut.

During my career, I realized a have a minor gift for explaining complex issues in a simplied manner from which most lay readers/listeners can benefit.

As 'disabled' I have mucho time on my hands, and filling the right hand with a mouse is easy enough.

Thanks again for the acknowledgement.

[MJShoe]

Rick, you really do have an incredible wealth of knowlege on the subject -- and the ability to explain it. I truly do appreciate the information you share on this site.

I notice that you have an unknown primary. Have you ever had the Pathwork Tissue of Origin test? My doctors were incredulous that I could have a 17-year metastases and would never give me a definite diagnosis -- they simply said that their "best guess" was that I have colon cancer. One doctor even wanted to treat me for pancreatic cancer on the hunch that the pancreas was the origin of my cancer. Anyway, about 18 months ago I had the Pathwork Tissue of Origin test and it confirmed that the colon cancer diagnosis is correct. It was comforting for me to have that information just to know that I was getting the right treatment.

Thanks again for your help.

MJShoe

[RixInPhx]

No, they didn’t do a PTO test, just KRAS-mutation.

Determination of CRC wa based on the nature of the secondary (large mass, about 1 cm thick by 10 cm high by 35 cm wide across the front of the belly (attached to the peritoneum) and the fact that all other possible source organs were fine and not involved.
And it responded immediately to Folfox + Avastin.

Of all the possible organs, it’s my understanding that only the colon can self-heal to the extent that the primary disappears (nothing on post-Dx colonoscopy or barium enema).
If the primary had been pancreatic, bladder, prostate, or appendix (the other candidates for such a peritoneal met), then that organ would have been significantly compromised, if not destroyed.

I'll be asking for a BRAF-mutation test, and will also enquire about the PTO test.

Thanks, Rick