Clinical Study

Gog-0212: A Randomized Phase III Trial Of Maintenance Chemotherapy Comparing 12, Monthly Cycles Of Single Agent Paclitaxel Or (Ct-2103) (Ind #70177), Versus No Treatment Until Documented Relapse In Women With Advanced Ovarian, Primary Peritoneal Or Fallopian Tube Cancer Who Achieve A Complete Clinical Response To Primary Platinum/Taxane Chemotherapy

Posted Date: Jan 29, 2014

  • Investigator: Eric Eisenhauer
  • Co-Investigator: Michael Blakeman
  • Specialties: Gynecologic Oncology, Cancer, Women's Health, Gynecology
  • Type of Study: Drug

In a prior study, a group of women with advanced ovarian cancer were treated with 5 or 6 cycles of chemotherapy until there was no sign of active cancer. The women were then divided into two groups. One group had no further treatment, while the second group continued to receive additional chemotherapy. Cancer came back more quickly in the untreated group than in the group that continued to receive treatment. Unfortunately, in this trial it was not possible to determine if the delay in the return of their cancer was associated with an improvement in how long they lived. A second question that was not answered by this completed study was whether the benefit of the delay in the return of their cancer was outweighed by the side effects of continuing the chemotherapy. In the current trial the investigators wish to examine whether women with advanced ovarian, primary peritoneal or fallopian tube cancer who have no evidence of disease after the completion of initial chemotherapy live longer if a specific treatment program is continued once a month for 12 months, versus stopping all chemotherapy until there is evidence of recurrence of the disease process. This study has three possible treatments. Two of the three use chemotherapy the other uses no further treatment. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer, and was the agent used in the trial noted above. The second agent, (CT-2103), is an experimental drug with anti-cancer activity similar to that of paclitaxel. It is possible that (CT-2103) will produce similar results to that achieved with paclitaxel, but with reduced side effects. This study is also interested in testing samples of your blood and some of your tumor if available from a previous biopsy or surgery. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.

Criteria:

You Have Ovarian, Primary Peritoneal Or Fallopian Tube Cancer That Has Been Confirmed By Surgery. Your Physician Has Informed You That You May Need Chemotherapy To Control The Growth Of Your Tumor And Reduce The Chance Of Recurrence. Standard Chemotherapy For Your Cancer Is Effective, But A Long-Term Cure Is Uncommon. Many Patients Will Eventually Develop Recurrent Disease And Need Additional Treatment. It Is Hoped That New Chemotherapy Combinations May Improve On The Success Achieved With Current Standard Treatment Programs. If You Are Under The Age Of 18, You Will Not Be Able To Participate In This Study.

Keywords:

Ct-2103, Fallopiane Tube Or Peritoneal Cancer, Gog 0212, Gynecologic Oncology, Ovarian Cancer

For More Information:

Michael Blakeman
513-584-5044
michael.blakeman@uc.edu

  • Search Clinical Studies

  • Research in the News

    UC Study Finds Organs from HCV Donors May Be Safe for Liver Transplant

    A UC researcher says livers from HCV patients who test positive for theantibody made to fight the disease may pose a modest risk of infection and beacceptable for transplant