NCI Trial IP Chemo
February 9, 2010 • Volume 7 / Number 3 | About the Bulletin| Archive/Search
Optimizing Chemotherapy with Bevacizumab for Ovarian Cancer
Name of the Trial
Phase III Randomized Study of Bevacizumab in Combination with Intravenous Versus Intraperitoneal Chemotherapy in Patients with Stage II, III, or IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Carcinoma (GOG-0252). See the protocol summary.
Dr. Joan Walker
Principal Investigator
Dr. Joan Walker, Gynecologic Oncology Group
Why This Trial Is Important
Women with ovarian cancer usually undergo surgery to determine the cancer’s stage and to remove as much malignant tissue as possible. Following surgery, these women are treated with chemotherapy in an effort to eliminate remaining cancer cells.
Typically, chemotherapy for ovarian cancer is administered intravenously (IV) and travels throughout the body in the blood (systemic chemotherapy). Research by the Gynecologic Oncology Group and others, however, has demonstrated that combining IV chemotherapy with the delivery of chemotherapy drugs directly into the peritoneal cavity (intraperitoneal, or IP, chemotherapy) is more effective in delaying cancer progression and helping patients live longer. Since tumors are often confined to the peritoneal cavity in patients with ovarian cancer (as well as in those with fallopian tube or primary peritoneal cancer, which are biologically similar diseases), IP chemotherapy may allow for a greater concentration of anticancer drugs in the area around the tumors while limiting side effects elsewhere in the body. Results published in 2006 from a phase III trial showing a median increase in survival of 12 months for women treated with IV plus IP chemotherapy led NCI to issue a clinical announcement encouraging use of the combined treatment.
Other recent developments in the treatment of ovarian cancer may offer benefits similar to those seen with IV plus IP chemotherapy while avoiding some of problems associated with it (such as increased toxicity and difficulty of administration). A recent phase III study using the chemotherapy drug paclitaxel intravenously on a weekly basis, along with IV carboplatin given every 3 weeks, yielded improvements in progression-free and overall survival compared with the same drugs given every 3 weeks. Additionally, treatment with the angiogenesis inhibitor bevacizumab has shown significant antitumor activity in phase II studies.
In this trial, patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cancer will be randomly assigned to receive one of three chemotherapy regimens:
IV paclitaxel weekly and IV carboplatin every 3 weeks
IV paclitaxel weekly and IP carboplatin
IV paclitaxel and IP cisplatin, followed by IP paclitaxel
All patients will receive IV bevacizumab during and following chemotherapy. Doctors want to know which of these three regimens is most effective in delaying progression and improving survival.
“This trial is designed to determine if IP therapy is still superior given the clinical advances seen with regimens using weekly IV paclitaxel and/or bevacizumab,” said Dr. Walker. “The added benefit of weekly IV paclitaxel and bevacizumab, in combination, for women with ovarian cancer has the potential to be a very exciting advance.”
For More Information
See the lists of entry criteria and trial contact information or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.
Comments
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NCI trial
I am in this trial. I am in the third group and will start cycle #5 on Wednesday. I was dx stage 3A, grade 3 clear cell OC on July 6th. It really hasn't been too bad. I was warned early on that the IP therapy is rough. It is really uncomfortable. I am pretty thin anyway and it's a lot of fluid that is put into the abdominal cavity. My CA-125 has dropped to 44 and they'll check it again when I start cycle 5. Good thing about the clinical trial is you are very closely monitored. I'm interested in hearing from any other women out there with clear cell - whether they've had recurrence, how soon, etc.0 -
Hi Taiga,taiga said:NCI trial
I am in this trial. I am in the third group and will start cycle #5 on Wednesday. I was dx stage 3A, grade 3 clear cell OC on July 6th. It really hasn't been too bad. I was warned early on that the IP therapy is rough. It is really uncomfortable. I am pretty thin anyway and it's a lot of fluid that is put into the abdominal cavity. My CA-125 has dropped to 44 and they'll check it again when I start cycle 5. Good thing about the clinical trial is you are very closely monitored. I'm interested in hearing from any other women out there with clear cell - whether they've had recurrence, how soon, etc.
I am following the same protocol as you are. But I have 2nd recurrence of endometrial. So I DID NOT QUALIFY for NCI Trial. I started Cycle 5 at PRENTICE HOSPITAL/Northwestern this morning. I have not had a difficult time with the chemo. Which arm are you on? I am
Day1 IV TAXOL IP CARBOPLATIN Day 8 IV TAXOL Day 15 IV TAXOL. No break in treatment. Repeat every 21 days for 6 Cycles.
I wanted all Warriors to that know that this trial is open and available in many states. It looks promising.
I had a CT SCAN last Thursday. The cancer has resolved. But we agreed to complete the 6 cycles. Good luck with cycle 5 and 6. I am interested in your final results.
Love to all Warriors.
Connie0 -
NCI trialparis11 said:Hi Taiga,
I am following the same protocol as you are. But I have 2nd recurrence of endometrial. So I DID NOT QUALIFY for NCI Trial. I started Cycle 5 at PRENTICE HOSPITAL/Northwestern this morning. I have not had a difficult time with the chemo. Which arm are you on? I am
Day1 IV TAXOL IP CARBOPLATIN Day 8 IV TAXOL Day 15 IV TAXOL. No break in treatment. Repeat every 21 days for 6 Cycles.
I wanted all Warriors to that know that this trial is open and available in many states. It looks promising.
I had a CT SCAN last Thursday. The cancer has resolved. But we agreed to complete the 6 cycles. Good luck with cycle 5 and 6. I am interested in your final results.
Love to all Warriors.
Connie
Hi Connie: I'm in the 3rd arm, IV Taxol and Avastin on day 1, IP Cisplatin on day 2, then IP Taxol on day 8. I'll do the 6 cycles and then start on the maintenance IV Avastin once every 3 weeks for 16 cycles. My day 1 is a Wednesday. The only time I feel bad is that weekend after Day 1 & 2. Started out not too bad - like a flu bug. But after the 4th cycle when all that starts building up, I was in bed pretty much all weekend. Luckily, no nausea. I get lots of anti-nausea pre-meds on chemo days and taken Emend on the 2 days after each chemo session. I'll get a CT after I finish the 6 cycles. I'm just concerned because I have clear cell. Not likely anything at this point will be big enough to show up on a CT scan and I've heard Avastin can screw with the CA-125. Good luck to you and congrats on the CT results!!!0 -
Taigataiga said:NCI trial
Hi Connie: I'm in the 3rd arm, IV Taxol and Avastin on day 1, IP Cisplatin on day 2, then IP Taxol on day 8. I'll do the 6 cycles and then start on the maintenance IV Avastin once every 3 weeks for 16 cycles. My day 1 is a Wednesday. The only time I feel bad is that weekend after Day 1 & 2. Started out not too bad - like a flu bug. But after the 4th cycle when all that starts building up, I was in bed pretty much all weekend. Luckily, no nausea. I get lots of anti-nausea pre-meds on chemo days and taken Emend on the 2 days after each chemo session. I'll get a CT after I finish the 6 cycles. I'm just concerned because I have clear cell. Not likely anything at this point will be big enough to show up on a CT scan and I've heard Avastin can screw with the CA-125. Good luck to you and congrats on the CT results!!!
I am happy that you are in this trial. I think it is a real advance in treatment. Where are you being treated? I think we are going to have great results. I wish it for more women.
Good luck with the last cycles. I have completed 5 Cycles. I will post after completion of Cycle 6.
Connie0 -
GOG-0252paris11 said:Taiga
I am happy that you are in this trial. I think it is a real advance in treatment. Where are you being treated? I think we are going to have great results. I wish it for more women.
Good luck with the last cycles. I have completed 5 Cycles. I will post after completion of Cycle 6.
Connie
Connie:
I am being treated in Springfield, MO. I feel very fortunate to have the opportunity to participate in a trial. My CA-125 dropped to 23.9 at the beginning of cycle 5 last week. Tomorrow I get the IP Taxol and then I'm off until 12/1 when I start the LAST cycle. I can't think of a better Chirstmas gift than to be done and hopefully get a clear CT. Good luck!0 -
Tagiataiga said:GOG-0252
Connie:
I am being treated in Springfield, MO. I feel very fortunate to have the opportunity to participate in a trial. My CA-125 dropped to 23.9 at the beginning of cycle 5 last week. Tomorrow I get the IP Taxol and then I'm off until 12/1 when I start the LAST cycle. I can't think of a better Chirstmas gift than to be done and hopefully get a clear CT. Good luck!
Thanks for response. I am being treated at Women's Prentice Hospital in Chicago. I begin Cycle 6 on November 29. I will let you know the results of the final CT Scan. We are blessed.
Connie0 -
GOG 0252
Hi
Just joined here. I was diagnosed Nov 12, 2010. Just got my baseline studies done to try to get into the trial. Will know maybe by next week. Luckily (?) I have Stage II but thought a trial would be good to get monitored more closely. Hope to hear from others how you are doing and what I can expect. I have not been back to work yet, but need to start back. Has anyone been working full time doing the trial? If not, how much have you been able to work? I'm nervous. Bought a wig, got my hair cut short, stupid stuff I guess.... just anxious.0 -
GOG 0252
Hi
Just joined here. I was diagnosed Nov 12, 2010. Just got my baseline studies done to try to get into the trial. Will know maybe by next week. Luckily (?) I have Stage II but thought a trial would be good to get monitored more closely. Hope to hear from others how you are doing and what I can expect. I have not been back to work yet, but need to start back. Has anyone been working full time doing the trial? If not, how much have you been able to work? I'm nervous. Bought a wig, got my hair cut short, stupid stuff I guess.... just anxious.0 -
GOG 0252
Hi
Just joined here. I was diagnosed Nov 12, 2010. Just got my baseline studies done to try to get into the trial. Will know maybe by next week. Luckily (?) I have Stage II but thought a trial would be good to get monitored more closely. Hope to hear from others how you are doing and what I can expect. I have not been back to work yet, but need to start back. Has anyone been working full time doing the trial? If not, how much have you been able to work? I'm nervous. Bought a wig, got my hair cut short, stupid stuff I guess.... just anxious.0
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