abraxane for platinum resistant?

[wesley71]

This is for my mom. We are all in the dark as too what the truth is. She had surgery with optimal debulking and 1% of tumor remaining. Staged at 3c. She then had the standard 6 cycles of carbo/paclitaxel and there was a .5 cm growth of a marker lesion in 3 months. Her initial ca-125 was 700 which dropped to 8 by the third chemo treatment. Due to the interval growth of the marker leison a 2nd look laproscopy was done revealing several pinhead sized "specks" on her diaphagram.  The Dr. then determined that she is platinum resistant and has just begun her on a clinical trial of weekly abraxane. The last ca-125 was 20, prior to the first abraxane treatment. Everyone involved in her medical care at the cancer institute seems to be very laid back and not overly concerned, and they continue to state that she has a good prognosis at this point. My mom is 63, in good health and  positive spirits but I am very worried. If the initial chemo failed doesn't that affect long term survival and also, if there has been metastatic disease identified in her diaphragm, even though it is very small, shouldn't she be under a more aggrssive protocol?  Finally as much as I am dying to believe in my heart that she truly does have a "good" prognosis, it seems that the evidence now points to the contrary. If that truly is the case why would her MDs insist she will be ok adn do well? Has anyone heard of abraxane for 2nd line chemo and is it effective? Thanks for your time reading this, and knowledge or advice will be greatly appreciated!

[medresc]

OK that puts a better light on it.  Any facility, small or large, that provides clinical trials and calls itself a 'cancer institute' must be endorsed by NCI.  For Abraxane, or any clinical trial, the effectiveness is not known and that's why it's a trial.  Phase 1 provides maximum toxicity and safety evaluations.  Phase 2 is used to determine if there is any action of the drug on the cancer (you get the drug but it's unknown if it really works).  Phase 3 is used when phase 2 shows activity (remember, even the major drugs today have low response rates...like 20 or 30 percent when used alone) and they have to show how it relates to the standard best treatment (for example compared to Doxil or in combination with another drug).  What is good today about phase 3 is that most will give you either the drug or a placebo which is common but they not give you the common treatment (such as Doxil) in either 'arm' of the study to ensure you are not just getting a 'placebo' and nothing else in the placebo arm.

Remember that Abraxane is really just Taxol...the main drug is no different...the only difference is it is encased so that more of the drug can be delivered to prevent infusion reactions (so more of the drug can be infused at one time compared to taxol).  Depending on what side of the fence you are on, Abraxane is considered a drug created for profit only (the guy who develped Taxol developed Abraxane right when Taxol's patent ran out...conincidence?).  Abraxane is FDA approved for breast cancer so they are trying to get into the ovarian cancer market to increase their market share (like any other pharmacutical).

Have your mom look into the OVATURE trial for Phenoxodiol if she is truely platinum resistant.  Platinum based drugs are the single best treatment for ovarian cancer.  http://www.ovaturetrial.com/

I looked quickly and found this information re: weekly abraxane:

Ongoing Trials: Weekly Regimen
At the American Society of Clinical Oncologists (ASCO) annual meeting held June 5 to 8, 2004, APP provided oral discussions of poster presentations describing a 106-patient phase II study of weekly Abraxane administration at 100 mg/m2 in taxane-refractory metastatic breast cancer patients, as well as a dose escalation phase I study of weekly Abraxane in advanced nonhematological malignancies.12 A second phase II nonrandomized, open-label, uncontrolled clinical trial of Abraxane, administered weekly at a higher dose of 125 mg/m2 in Taxol-resistant patients with metastatic breast cancer, is currently recruiting patients.13 These studies are designed to investigate the safety and efficacy of Abraxane given IV once weekly for three weeks, followed by a rest week with continuation of the cycle until safety problems or treatment failure occurs. The study utilizing Abraxane at 100 mg/m2 weekly demonstrated promising results in a very poor prognostic breast cancer population whose tumors grew while on Taxol or Taxotere therapy. In this patient population, disease control with absence of disease progression was noted in 30% (32/106) with 29% of patients demonstrating on further progression at six months. Abraxane was extremely well-tolerated at the 100 mg/m2 dose administered weekly with no evidence of severe hypersensitivity without premedication, a 1% incidence of grade 4 neutropenia without granulocyte colony-stimulating factor, no grade 4 nonhematological toxicity, and only a 4% grade 3 sensory neuropathy.14

An additional four studies were found that are currently recruiting patients: Abraxane in treating patients with inoperable locally recurrent or metastatic melanoma; patients with chemotherapy-naive stage IV non–small cell lung cancer; patients with advanced non­hematologic malignancies; and patients with chemotherapy-naive advanced non–small cell lung cancer.15  

[wesley71]

Hey thanks for your answers, interest and time. I should have said it was moms' idea to ask for a clinical trial because the increased monitoring and c.t. scans give her piece of mind. I just hope that the Docs will really be honest when it comes to her best shot as far as clinical trial versus standard therapy. I really hope it is not a scenerio like they think there is still time enough to "try" this and see if it works. What I am really trying to say is  I don't my mom being used as a lab rat when something else should and could be done with more predictable results, even though the docs assure us that because the Abraxane trial is in phase three it does show a good response rate. I just wish I could find out more research data regarding this trial. And yeah, mom is getting treatment by a major cancer institute endorsed by the NCI.

[medresc]

Good for you....you are doing the right thing by questioning what is going on.  First off, there are good oncologists and centers.  I/we have no idea how yours is or who they are.  That being said 'cancer' is a huge business with plenty of profits.  Going straight into a clinical trial is 'fishy' at the least.  Weekly Abraxane seems to be taking the approach of weekly taxol which, yeah, could or could not be helpful.  If she is 'platinum' resistant, she can also be resistant to taxanes like taxol or abraxane so that's a 'iffy' statement the oncologist made (you will learn that most of them just 'guess' based on their experience...that's why they are never overly concerned...).  

Second, many oncologists (despite research to the contrary) believe older patients (ahem, most of which are ovarian cancer patients anyways) should not get 'agressive' chemotherapy.  This is wrong.  Research shows that agressive chemo benefits older patients.  Unless there is some overriding medical issue, patients should have agressive chemo despite their age.

The fact that her CA125 went down is excellent...you want that.  Despite which way the disease turns (cure or otherwise), a 'ca-125' style remission is what you want by the third cycle and at the end of the treatment.  

Your question about the initial chemo failing...well yes and no sorta...you have a loaded question! :)  Do not be scared but the vast majority of ovarian cancer patients do have a recurrance even after an excellent first chemo...it just happens.  What the oncologist looks at is the time since recurrance to determine if they can use platinum based chemo again.  I'm assuming your mom was *under* 6 months since last chemo?

Anyways that doesn't mean she cannot use cheo again even if she is platinum resistant.  For example she can have *weekly* taxol and have an effect (yeah really!) and also the phase III trial of phenoxodiol (ovature trial) makes platinum resitant ovarian cancer sensitive again (see if you can get her on that...if she doesn't get the drug, she can get weekly chemo at least).

Now, you should ask him why she is not on Doxil.  Or better yet, why not on double agents like Doxil and 5FU or Doxil and Eloxatin (Oxaplatin).  Both have shown really outstanding results in ovarian cancer patients.

You should write down questions for the oncologist prior to going in...press the issue you want to know specifics.  If your mom does not want to hear it, speak to the oncologist alone.  Do not let them dismiss you and get answers...it's your right as your moms representative.

Bottom line:  your mom should be directing the course of her treatment, not the oncologist.  The oncologist is the specialist but should be asking what *she* wants and offering other *alternative* chemo treatments.

They are not Gods!  Keep fighting! :)

[Helmar]

Hello... I'm just wondering why your Mum's Doctors chose this particular drug, when there are so many others 'out there'?  She's done well to get the CA.125 down from 700 to 8 after only 3 treatments, so it seems that the Carbo/Taxol was working well. I've had many different chemos in the almost 4 years since I was dx, but not Abraxane, so I'm sorry I can't help you with any info on that one.Some of the other ladies here may be able to shed some more light on it for you though.
I just want to wish your Mum all the best, and it's good that she has a good attitude towards fighting this horrid cancer.   Hugs to you and your Mum....Helen...