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GOG 0218 study closed

Shamrock2009
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Hi GOG 0218 particpants!
The GOG 0218 study has recently closed after meeting its accrual goals. After adequate data is collected we should be hearing onto what arms we were randomized. The end of study information will tell us if Avastin is indicated either during first 6 cycles with Taxol/Carboplatin or if Avastin proves to be advantageous for 14 cycles of maintenance or both.
Of course, according to the protocol women who experience recurrence will be unblinded immediately so that treatment decisions can be made.

Explore topics in this discussion:

Cancer Taxol Surgery Avastin Breast cancer

15 replies

catealpower

Shamrock great news. I just had cycle 8 yesterday. So far so good. How many cycles did you have?

Sunny01

Hi Shamrock.
Was wondering if the study closed, does that mean that those midway through it will continue until our scheduled end dates? For example, I am scheduled to receive Bevacizumab or placebo until December 25th (Merry Christmas to me!) every 3 weeks. My research nurse had told me that sometimes if a medication becomes approved for use (for example Avastin for OC) that they then stop the study. I have been concerned because we feel I have been receiving it based on CT results (tumors continuing to shrink each time even though I finished carbo/taxol in December) and my side effects that continue, I wanted to stay on it as long as possible and knew I wouldn't have to deal with my insurance company until after the study ended as far as approval to continue the use of it. I have alot of faith in this medication for myself. I am stage IV with tumors on my liver not seen at the time of surgery, the combination of medications have been remarkable at shrinking those tumors (one was 8cm and has shrunk to just under 1.5 cm on my last CT Scan).

verbena

i have the same question...i just finished the carbo/taxol part of my life (whew!) but i still am scheduled for cycle 7 for the study. are they going to cut me off?

so far i've done well but i wanted to continue with the study partly because they continue monitoring me and partly because i want the avastin since it seems to work as advertised so to speak from what i've read.

tex2step

I was also on the GOG 0218. I completed the first six rounds of this protocol in Feb 09, but was removed on the 7th round due to a blood clot in my descending aorta. I still don't know if I received the Avastin in rounds 2 thru 6, but I am anxious to know.
I am currently participating in a vaccine study and in remission for five months.
Please stay in touch so that we can share with each other the outcome of this trial.
Thanks for letting us know that the study is in it's final stages as I had not thought to check on it.
Stacey

Shamrock2009

Hi Catealpower,
I completed the first 6 cycles (part 1) on June 8,2009. My June Ct scan was NED (had 4 suspicious areas at the baseline scan) and CA 125 went frm 831 down to 7.
Last Monday I received the 2nd of the additional 14 cycles of Placebo/Avastin.

Shamrock2009

Hi Sunny01,
Great response for you!!
I found that the study was closed on the NCI clinical trial site that it was closed but no explanation.
I asked my GYN Oncologist when I saw her Monday and she said that it closed because the total accrual has been met this not halfway!!
I am sure that the study results will not be into the FDA and approved for either first line or maintenance before you finish in December. Remember the study is trying to prove that Avastin is the best treatment for first line when given with Taxol and Carbo and also as a maintenance therapy with Avastin alone. So this is really two studies in one and either or both regimens or none will have to be approved by the FDA to make drug available commercially.
If early study results show that Avastin is an advantage in either Part 1 or 2 then GOG will unblind study and inform Physicians what their patients received --for example if I have not been getting Avastin during this maintenance period my physician will be notified so that a decision can be made to put me on Avastin if it has shown a significant advantage to do so and this will be done before FDA approval

Shamrock2009

Hi Verbena,
Se my response to Sunny01. If that did not answer your questions let e know.

Shamrock2009

Hi Tex2step,
Glad to hear you are in remission!! Were you in remission before the vaccine trial?
I thought they unblind women who have complications like you. I have a copy of the full protocol and will check it when I have an opportunity. My experience as a medical oncology research nurse for 30 years (ironically) comes in handy.

tex2step

Hello Shamrock2009,
Thanks for all you are doing to help keep us posted on this clinical trial. It was decided not to unblind the study unless I have a re-occurrence, but I was not allowed to continue with Phase II.
I was diagnosed as PPC IIIC Sept 08 and I have never had any tumors that show up on CT . The CA125 seems to be the only indicator for me just now. It was at 11 after the first six rounds of chemo and jumped up to 33 just after re-attachment of my colon from a colostomy. It has now returned to 13 as of last month.
I am currently on a vaccine trial that targets two peptides(GP2 and AE37 plus GM-CSF). This vaccine has been tested on HER2 breast cancer patients singularly and is now testing on OVCA patients as as doublet who have either the HLA-A2+ or the HLA-A3+ in their blood test. The idea is to stimulate your own immune system to respond against HER2/neu.
I don't know if it will work, but it is worth a try. I will let you know how it goes - I have two more cycles and another year of follow up.
Please keep us posted on any of the ladies in GOG 0218 as we are all interested in the results for all our sisters in this fight.
Stacey

Shearaw

I hope that everyone on the study now knows that you will continue the treatment path that you have been randomized into until it's conclusion. Since one of the success measures of these trial is median time to disease progression, it is my great hope that the data for the Avastin arms will take a long time to come in...meaning that participants have lengthy remissions!!!! I would imagine that if there is indication of a significant increase in remission times, they will publish the indicating data and try to move forwad with FDA approval directly.

Hurray for all of us who have been able to do this or other trials. We are doing our best to help the next generation of women, and hopefully ourselves.

Shamrock2009

Hi Shearaw,
Actually if the early data indicates that Avastin is advantageous the study will be unblinded before everyone completes their regimens. Their physicians will be notified so that they can make a decision to give Avastin if the participants did not receive it in the trial. It is considered unethical not to do this. I have seen this happen with other drugs during my clinical trials career and my Oncologist mentioned this when I saw her last Monday.
And I am sure if the early data shows positive end points Genetech/Roche will submit to the FDA very quickly to get approval for this indication(s) (either as first- line with Taxol /Carbo or as a Maintenance treatment or both indications) so that they can start making more money on Avastin besides metastatic breast and colon cancers along with first-line NSCLC that are already approved indications.
Avastin is now used in recurrent OVCA without formal indication FDA approval because of the positive results of the recurrent study.
(I was a study coordinator nurse on the Avastin colon study)

Shearaw

Hi Shamrock, I guess that I was using a technically ignorant way of trying to say something similar. "Quick" is a relative term in our world. GOG 218 has taken nearly 4 years to accrue all 2000 patients. For Advanced OvCa stages I was told that the median time to progression is 18 months. If Avastin improves that by at least 6 months, it seems to me that data would just be beginning to compile for the initial participants. If that is sufficient to go to the FDA, great news! But, will the original women in the non-placebo arm of GOG 218 still be tracked to compile a valid final statistic for improvement in time to progression?

Shamrock2009

Hi Shearaw,
GOG 0218 was open to accrual 9/26/2005. However by the time each Cancer Center who signed on to participate early needed to receive approval through their IRB's for accrual and were probably not accruing until 8 or more weeks after 9/2005. Other Cancer Centers were added on as time went by.

GOG has early data information from the participants who unfortunately have already had recurrence--- because of recent amendment to the protocol requiring that those who have recurrence or progression (whether the participants are in Part 1 or Part 2 ) must be unblinded so that their physicians will know if they have received Avastin and if not can then receive it. This change was required because of the evidence that Avastin is advantageous for recurrent OVCA found in earlier studies.

Part I of the study looks at response to the combination of Taxol/Carbo and Avastin or placebo so after 6 cycles of each participant that they will have data to see if this combination is better, same or worse then use of Taxol/Carbo alone--Ct scans required after 3 and 6 cycles--so response data will be know early on.
Definitely Part 2 (those who have not had recurrence or progression on Part 1) data will take longer to evaluate because it lasts for 14 cycles (Avastin/Placebo) with Ct scan every 4th Cycle. (I have recently received #2 cycle)

GOG does not need all participants survival data to see that there is a % of proportionally negative or positive results. There are statistical criteria that can look at a certain % of the data to see what the end results will show. This is not my area of expertise by any means but I do know that this is important. For example most studies are evaluated midway to see if they should stopped or continued in relation to response , toxicity and quality of life results.

Accrual to 0218 picked up when the disease eligibility requirements were refined in amendments in 2006, 2007and 2008. These changes to the protocol made the study open to more women especially those with optimally debulked OvCa, PPC,
and FTC who were not permitted to enroll earlier.

The study is looking for Primary endpoint: Progression -free survival

Secondary Endpoints:
Overall Survival
Response Rate
Toxicity
Quality of Life
Translational Research ( Looking at angiogenic markers in relation to response and also looking at gene expression correlating with survival)

Hopefully our participation in this study will unlock answers to all of the endpoints listed above. We should pat ourselves on the back for helping OvCa, PPC and FTC research.

hinsopa

Look forward to hearing the results. I started the trial Sept. 2006, completed all 22 infustions and was monitored until my recurrence in May 2009. I was unblinded and learned I did not get the avastin at all. I decided to enter GOG 213 and was randomized to receive it this time so I will be interested. Once chemo is completed, I can continue with avastin as long as it is working.
The worse side effect for me is a very, very dry nose with sores. Anyone had this and found a good treatment?
Patsy

Shearaw

Shamrock, Thinks for the clarification and detailed explanations.

Hinsopa, Using a neti pot helped me temendously.

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