Clinical trial (third line treatment) lurbinectedin and irinotecan

Posted by ro0891 @ro0891, Jun 14, 2023

Starting a clinical trial this week for stage iv pancreatic cancer. Trial doesn’t target a specific mutation but it does target neuroendocrine tumors. Was on Gem/Abrax for few months and cancer started to show resistance. Options were explore trials or stay on chemo and eventually comfort care and hospice. Been off of chemo for 2 weeks for a flush to start the trial drug and cancer has progressed- symptoms have worsened. Will be starting a trial with the drugs lurbinectedin and irinotecan. The lurbinectedin is the trial drug. Just wanted to get anyones thoughts on trials and if they’re familiar with the trial drug. It is approved for Small Cell Lung Cancer but is now being tested with gastro cancers.

Interested in more discussions like this? Go to the Pancreatic Cancer Support Group.

A have a basic familiarity with a new trial testing lurbenectedin heading by Dr. Erkut Borazanci of HonorHealth as in its mode of action but not much more because of the clinical study just getting started. I do have experience with clinical trials so I can comment regarding my experience.

When I was facing a diagnosis of stage IV disease in 2012, even before starting standard of care treatment, I began looking at clinical trials. It is said that those with later stage pancreatic cancer participating in clinical trials may have better outcomes than standard of care. Every drug used in cancer treatment began as a clinical trial and had to show efficacy that was equal to or better in some way if it was being tested against an existing drug. My search became easier when testing revealed a genetic mutation that was targetable. It took 14 months until I found the trial that was a best match to my set of criteria matching the trial’s eligibility criteria.

For those not having genetic mutations or actionable biomarkers, a third type of clinical trial tests small molecule drugs. This is a very active area of clinical research and from understanding the mechanisms of how a drug works at the molecular level, drugs that were developed for other types of cancers or conditions offer the potential to treat other types of cancers. The clinical study I was in first was for a drug first tested on ovarian cancer and got approval. Then it was tested on breast cancer and approved for that use. Next was pancreatic and now it is being used for prostate as an example of how a drug’s application of use can evolve. It doesn’t work for every patient but for some, it has made the difference.

With clinical trials, a study participant is observed much more closely by the study team than someone doing standard of care. When I entered my trial, searching for treatments did not stop. I continued looking for other options should the trial not work. I wanted to be prepared and with limited targeted therapies, focused on small molecule drug trials. Fortunately the drug I obtained as targeted therapy with the objective of long-term maintenance monotherapy continues to work and I remain on the drug which continues to be provided free of charge for over 8.5 years now. I continue to be closely and frequently monitored for the drug which is well tolerated.

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@stageivsurvivor

A have a basic familiarity with a new trial testing lurbenectedin heading by Dr. Erkut Borazanci of HonorHealth as in its mode of action but not much more because of the clinical study just getting started. I do have experience with clinical trials so I can comment regarding my experience.

When I was facing a diagnosis of stage IV disease in 2012, even before starting standard of care treatment, I began looking at clinical trials. It is said that those with later stage pancreatic cancer participating in clinical trials may have better outcomes than standard of care. Every drug used in cancer treatment began as a clinical trial and had to show efficacy that was equal to or better in some way if it was being tested against an existing drug. My search became easier when testing revealed a genetic mutation that was targetable. It took 14 months until I found the trial that was a best match to my set of criteria matching the trial’s eligibility criteria.

For those not having genetic mutations or actionable biomarkers, a third type of clinical trial tests small molecule drugs. This is a very active area of clinical research and from understanding the mechanisms of how a drug works at the molecular level, drugs that were developed for other types of cancers or conditions offer the potential to treat other types of cancers. The clinical study I was in first was for a drug first tested on ovarian cancer and got approval. Then it was tested on breast cancer and approved for that use. Next was pancreatic and now it is being used for prostate as an example of how a drug’s application of use can evolve. It doesn’t work for every patient but for some, it has made the difference.

With clinical trials, a study participant is observed much more closely by the study team than someone doing standard of care. When I entered my trial, searching for treatments did not stop. I continued looking for other options should the trial not work. I wanted to be prepared and with limited targeted therapies, focused on small molecule drug trials. Fortunately the drug I obtained as targeted therapy with the objective of long-term maintenance monotherapy continues to work and I remain on the drug which continues to be provided free of charge for over 8.5 years now. I continue to be closely and frequently monitored for the drug which is well tolerated.

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What drug is it that’s working so well for you?

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The gem/Abrax slowed things down but it has become resistant to chemo and rapidly grew. Tumor got much bigger on my off week while waiting for trial.

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@stageivsurvivor

A have a basic familiarity with a new trial testing lurbenectedin heading by Dr. Erkut Borazanci of HonorHealth as in its mode of action but not much more because of the clinical study just getting started. I do have experience with clinical trials so I can comment regarding my experience.

When I was facing a diagnosis of stage IV disease in 2012, even before starting standard of care treatment, I began looking at clinical trials. It is said that those with later stage pancreatic cancer participating in clinical trials may have better outcomes than standard of care. Every drug used in cancer treatment began as a clinical trial and had to show efficacy that was equal to or better in some way if it was being tested against an existing drug. My search became easier when testing revealed a genetic mutation that was targetable. It took 14 months until I found the trial that was a best match to my set of criteria matching the trial’s eligibility criteria.

For those not having genetic mutations or actionable biomarkers, a third type of clinical trial tests small molecule drugs. This is a very active area of clinical research and from understanding the mechanisms of how a drug works at the molecular level, drugs that were developed for other types of cancers or conditions offer the potential to treat other types of cancers. The clinical study I was in first was for a drug first tested on ovarian cancer and got approval. Then it was tested on breast cancer and approved for that use. Next was pancreatic and now it is being used for prostate as an example of how a drug’s application of use can evolve. It doesn’t work for every patient but for some, it has made the difference.

With clinical trials, a study participant is observed much more closely by the study team than someone doing standard of care. When I entered my trial, searching for treatments did not stop. I continued looking for other options should the trial not work. I wanted to be prepared and with limited targeted therapies, focused on small molecule drug trials. Fortunately the drug I obtained as targeted therapy with the objective of long-term maintenance monotherapy continues to work and I remain on the drug which continues to be provided free of charge for over 8.5 years now. I continue to be closely and frequently monitored for the drug which is well tolerated.

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Can you share the clinical trial information?

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PM1183-A-014-15
LURBINECTEDIN (PM01183)

https://www.google.com/search?q=PM1183-A-014-15+LURBINECTEDIN+(PM01183)&rlz=1C5CHFA_enUS853US853&oq=PM1183-A-014-15+LURBINECTEDIN+(PM01183)&aqs=chrome..69i57j0i546l3.342j0j7&sourceid=chrome&ie=UTF-8

The trial is now being studied no GI cancers- it has been used for years for SCLC and showed promising results. This particular trial targets neuroendocrine tumors - so it is the best one available currently for my Dads tumor. It is a combo of irinotecan and lurbinectedin. On day one you receive both drugs, followed by 4 days of blood work to monitor toxicity levels, as well as wbc shots for 4 days. On day 8 irinotecan again followed by one week off. REPEAT (so every 21 days you receive the trial drug).

We have not started the trial yet. Albumin needs to be at a 3.0 my dads has been hovering at a 2.8- so we are unable to start the trial until he reaches that threshold. Protein intake and Vit D are the only remedies to raise it, so it takes some time. Cancer is getting worse, so we are hoping to hit the threshold this coming week and start the trial next Friday.

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@stageivsurvivor

A have a basic familiarity with a new trial testing lurbenectedin heading by Dr. Erkut Borazanci of HonorHealth as in its mode of action but not much more because of the clinical study just getting started. I do have experience with clinical trials so I can comment regarding my experience.

When I was facing a diagnosis of stage IV disease in 2012, even before starting standard of care treatment, I began looking at clinical trials. It is said that those with later stage pancreatic cancer participating in clinical trials may have better outcomes than standard of care. Every drug used in cancer treatment began as a clinical trial and had to show efficacy that was equal to or better in some way if it was being tested against an existing drug. My search became easier when testing revealed a genetic mutation that was targetable. It took 14 months until I found the trial that was a best match to my set of criteria matching the trial’s eligibility criteria.

For those not having genetic mutations or actionable biomarkers, a third type of clinical trial tests small molecule drugs. This is a very active area of clinical research and from understanding the mechanisms of how a drug works at the molecular level, drugs that were developed for other types of cancers or conditions offer the potential to treat other types of cancers. The clinical study I was in first was for a drug first tested on ovarian cancer and got approval. Then it was tested on breast cancer and approved for that use. Next was pancreatic and now it is being used for prostate as an example of how a drug’s application of use can evolve. It doesn’t work for every patient but for some, it has made the difference.

With clinical trials, a study participant is observed much more closely by the study team than someone doing standard of care. When I entered my trial, searching for treatments did not stop. I continued looking for other options should the trial not work. I wanted to be prepared and with limited targeted therapies, focused on small molecule drug trials. Fortunately the drug I obtained as targeted therapy with the objective of long-term maintenance monotherapy continues to work and I remain on the drug which continues to be provided free of charge for over 8.5 years now. I continue to be closely and frequently monitored for the drug which is well tolerated.

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Did you have neuro or adeno tumors?
Just visited with key Dr at JH; he tells me there is not a targeted therapy-vaccine or immontherapy-yet for KRAS. Mutation/Adenocarcinoma.
Neither is there a recommended maintenance therapy.
Apparently you are “lucky” if you have BRCA mutation as they have found extraordinary responders in this category with a particular therapy or two

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My dad has a neuro tumoe. KRASG12D CHECK2
There are some being developed. I have my dad on a wait list for the MRTX1133 Drug. It is being offered at several different hospitals around the country. Problem is - it is in early stages and they're conducting the trial on 3 people at a time right now (from my understand).

Here is the link

https://www.google.com/search?q=mrtx1133&rlz=1C5CHFA_enUS853US853&oq=mrt&aqs=chrome.1.69i57j69i59j0i433i512j0i512l2j69i61l2j69i65.2426j0j4&sourceid=chrome&ie=UTF-8
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Interesting. My next-gen sequencing says I might qualify for a trial involving lurbinectedin through Jazz Pharmaceuticals, and I have adenocarcinoma. Is this the same trial you all are discussing? The paper doesn't mention irinotecan, FWIW.

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I'm not sure which pharmaceutical company it is with. I'd have to get back to you on that. But I do know it is in combination with the Irinotecan.

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@ro0891

My dad has a neuro tumoe. KRASG12D CHECK2
There are some being developed. I have my dad on a wait list for the MRTX1133 Drug. It is being offered at several different hospitals around the country. Problem is - it is in early stages and they're conducting the trial on 3 people at a time right now (from my understand).

Here is the link

https://www.google.com/search?q=mrtx1133&rlz=1C5CHFA_enUS853US853&oq=mrt&aqs=chrome.1.69i57j69i59j0i433i512j0i512l2j69i61l2j69i65.2426j0j4&sourceid=chrome&ie=UTF-8

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@ro0891 Thanks for the info. I know you're not a dr or a gene specialist, but would you happen to know if this drug might be applicable (it it works in trials) for all KRAS gene mutations? My husband has the KRAS G12V gene mutation. ALso- do you know which hospitals are offering this? (My husband is at Dana Farber, Boston. ) I"ll check w his dr. I don't recall seeing this trial last time I checked their website, but will check again.

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