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Ovarian Cancer Clinical Trial Ovarian Cancer Clinical Trial

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Unread 11-10-2003, 05:32 PM
Ovarian Cancer Clinical Trial

Hi Ladies,

With all of my worry and concern over my sister's breast surgery and biopsy today, I forgot to ask if anyone else DX with OC has heard of or has any further knowledge of the following clinical trial for OC? My sister is a participant in this trial that will have her on 2 different regimens of chemo for 1 year as opposed to 6 months:

Phase III Randomized Trial of Induction Chemotherapy with Gemcitabine and Carboplatin Followed by Paclitaxel Consolidation versus Paclitaxel and Carboplatin Followed by Paclitaxel Consolidation in Patients with Advanced Primary Epithelial Ovarian or Primary Peritoneal Cancer
Trial ID: 02044

This research study is open to subjects that have ovarian cancer or primary peritoneal cancer, which behaves like ovarian cancer. The purpose of this research study is to look at ways to improve the treatment of ovarian and ovarian-like cancers by comparing a standard combination of chemotherapy (paclitaxel plus carboplatin) with another combination of chemotherapy (gemcitabine plus paclitaxel) that has also shown activity in these types of cancer. In addition, studies have suggested that there might be a delay in the time it takes for the disease to return if patients receive monthly paclitaxel for 1 year after completing treatment with combination chemotherapy. Therefore, following combination chemotherapy, all patients will receive paclitaxel therapy for one year as long as it is tolerated. Research participants who are eligible to participate in this trial will be randomized (similar to flipping a coin) to receive one of two drug regimens (paclitaxel/carboplatin or gemcitabine/carboplatin). If the cancer should come back within 6 months after the end of chemotherapy or during chemotherapy, the cancer will be considered to be resistant to carboplatin. Research participants would then have the opportunity to switch to the other drug they have not received (gemcitabine or paclitaxel) without the carboplatin. The drugs, paclitaxel and carboplatin, are approved by the Food and Drug Administration (FDA) for the treatment of ovarian cancer. Gemcitabine is approved by the FDA for the treatment of cancer of the pancreas.

Thanks in advance~
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Unread 11-10-2003, 05:43 PM
Ovarian Cancer Clinical Trial

Hi, Heni.

If I had been offered this trial, I might well have participated in it. As it was, I was offered a different trial that included the possibility of being randomized to one of five different arms -- one of which contained a drug I did not want to take.

From what I've heard, Gemcitabine, or Gemzar, has been shown to be very promising, especially when coupled with Carboplatin. I do not, however, know whether this combination is better than the Carboplatin/Taxol combination. That is something that you will have to ask your doctors. I'm sure they have some thoughts on which combination is working better. If they don't, find another hospital that is offering this trial and contact the research nurse there, then ask her/him.

I was interested to read the part where it says that weekly Taxol (Paclitaxel) has been shown to delay recurrence. I am currently the only ovaca patient at my HMO who is doing the weekly Taxol (just had a treatment today). I decided to do it for as long as my body could tolerate it. So far, I am tolerating it well. I am noticing some arthritis in my hands in the morning (so fun, since I'm only 38), but my doctor said that was to be expected. But other than that, and feeling chemoish for two days, I'm OK.

Whether or not to participate in a clinical trial is a decision that many of us have faced. Some have chosen to participate. Others have chosen not to. The decision is ultimately yours. I would try to do a bit of research on your own to determine whether the Gemzar/Carbo regime offers more promise than the Carbo/Taxol regime. Even though the results of the study aren't yet available, you should be able to get some sort of "observational" data if you ask enough questions.

Good luck making this decision! :-)
Unread 11-10-2003, 05:57 PM
Ovarian Cancer Clinical Trial

Hi Siren~

My sister will be getting the Taxol/Carboplatin the last 6 months.
It's just the first 6 months with the experimental combination.

Thanks for your reply.

Blessings to you~
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Unread 11-10-2003, 05:59 PM
Ovarian Cancer Clinical Trial

OK. I'm confused. Are they saying that she would get the Gemzar/Carbo for six months and THEN get Taxol/Carbo for another six months . . . and THEN get 12 months of weekly low-dose Taxol?
Unread 11-10-2003, 07:19 PM
Ovarian Cancer Clinical Trial

No, the first 6 months is the trial, the second 6 months is the taxol/carboplatin...no taxol until the last six months.
Unread 11-10-2003, 07:34 PM
Ovarian Cancer Clinical Trial

I was asked to be in that study but from what I was told it was 8 treatments instead of 6 and that you would get definately get the taxol and carboplatin with the third drug being one of the other two you were talking about. I do not remember it being for a year though.

For my own reasons, I chose not to be in the study.


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