A RANDOMIZED PHASE III TRIAL OF EVERY-3-WEEKS PACLITAXEL VERSUS DOSE DENSE WEEKLY
PACLITAXEL IN COMBINATION WITH CARBOPLATIN WITH OR WITHOUT CONCURRENT AND
CONSOLIDATION BEVACIZUMAB (NSC #704865, IND #7921) IN THE TREATMENT OF PRIMARY STAGE III
OR IV EPITHELIAL OVARIAN, PERITONEAL OR FALLOPIAN TUBE CANCER
PI: David G. Mutch, MD • Coordinator: Lynne Lippmann, CCRP
- Sponsored by Gynecologic Oncology Group (NCI), GOG 262 / ACRIN 6695
A Phase III randomized study for the treatment of Stage III (and some Stage II) suboptimal or Stage IV primary ovarian,
peritoneal or fallopian tube cancer. Patients who have received prior neoadjuvant chemotherapy with interval cytoreduction
are eligible for this study as well. Patients are randomized to Carboplatin/Paclitaxel on Day 1 versus Carboplatin Day 1
and Paclitaxel Days 1, 8 and 15 of a 21 day cycle. Each patient may choose wither she wants to receive Bevacizumab in
combination with her chemotherapy as well as maintenance therapy with Bevacizumab. There is an imaging component
using perfusion CT scans available to those patients who opt to participate as Washington University is an ACRIN (American
College of Radiology Imaging Network) site. Target accrual group-wide: 625
A PHASE II RANDOMIZED DOUBLE-BLIND TRIAL OF A POLYVALENT VACCINE-KLH CONJUGATE (NSC
748933 IND# 14384) + OPT-821 VERSUS OPT-821 IN PATIENTS WITH EPITHELIAL OVARIAN, FALLOPIAN
TUBE, OR PERITONEAL CANCER WHO ARE IN SECOND OR THIRD COMPLETE REMISSION
PI: David G. Mutch, MD • Coordinator: Lynne Lippmann, CCRP
- Sponsored by Gynecologic Oncology Group (NCI), GOG 255 - Cooperative Group
This is a Phase II vaccine study for patients who have achieved a 2nd or 3rd complete response (CR) defined as CA125 level
within normal limits, negative physical, exam and CR or MRI showing no evidence of disease. Patient must have undergone
cytoreductive surgery and at least one platinum-based treatment as part of their primary therapy. Treatment includes the
immunologic adjuvant OPT-821 given subcutaneously +/- polyvalent vaccine. Treatment is given on weeks 1, 2, 3, 7 and 11
and then every 3 months for a total of 11 vaccines. Target accrual group-wide: 164
A RANDOMIZED TRIAL OF BUFFERED VS NON-BUFFERED LIDOCAINE WITH EPINEPHRINE FOR
CERVICAL LOOP EXCISION
PIs: Nora Kizer, MD; L. Stewart Massad, MD • Coordinator: Lynne Lippmann, CCRP
- Sponsored by Gynecologic Oncology Group (NCI)
A randomized 2 arm study comparing two different lidocaine solutions commonly used in the performance of a LEEP. At
the time of their procedure, patients who have consented to participate in the study receive their local anesthesia for the LEEP
with either buffered or non-buffered lidocaine. The physician is blinded as to which lidocaine is being used. At the end of the
procedure, patients are asked to score the pain they felt during the procedure using a visual scale on a paper questionnaire.
Study participation ends once their pain score is completed. Target accrual group-wide: 54
A LIMITED ACCESS PHASE I/II TRIAL OF PACLITAXEL, CISPLATIN AND CTEP SUPPLIED AGENT ABT-
888 (VELAPARIB) (IND #77840, NSC #737664) IN THE TREATMENT OF ADVANCED, PERSISTENT, OR
RECURRENT CARCINOMA OF THE CERVIX
PI: David Mutch, MD • Coordinator: Lynne Lippmann, CCRP - Sponsored by Gynecologic Oncology Group (NCI), GOG 0076HH - Cooperative Group
This is a Phase II study with a Phase I lead-in which will also be performed at Washington University to determine the final
dose to be used in the Phase II study. Patients will receive the chemotherapy drugs paclitaxel (given on day 1) and cisplatin
(given on day 2) , given intravenously, in addition to the investigational drug ABT-888, a PARP inhibitor available as an oral
capsule twice daily on days 1-7. Cycles are repeated every 21 days. There is a translational research component to this study
involving tumor tissue taken from a previous biopsy or surgery as well as additional blood draws for those patients entered in
the Phase I portion of the study. Treatment will continue unless there is evidence of disease progression, there are side effects
prohibiting further therapy, or the study is stopped. Target accrual group-wide: 111
A PHASE II EVALUATION OF IXABEPILONE (IND #710428) IN THE TREATMENT OF RECURRENT OR
PERSISTENT CARCINOSARCOMA OF THE UTERUS
PI: David Mutch, MD • Coordinator: Lynne Lippmann, CCRP
- Sponsored by Gynecologic Oncology Group (NCI), GOG 130F - Cooperative Group
This is a Phase II study exploring the use of Ixabepilone, an epothilone drug. Epothilones are similar to paclitaxel but have
the potential to work on cells that are resistant to paclitaxel. Patients are treated on day 1 of each 21-day cycle and are given
the drug intravenously. There is a translational research component to this study involving tumor tissue taken from a previous
biopsy or surgery. Treatment will continue unless there is evidence of disease progression, there are side effects prohibiting
further therapy, or the study is stopped. Target accrual group-wide: 34
A RANDOMIZED PHASE III EVALUATION OF DOCETAXEL (NSC#628503)
AND GEMCITABINE (NSC#613327) PLUS G-CSF WITH BEVACIZUMAB (NSC #704865, IND#7921) VERSUS
DOCETAXEL (NSC#628503) AND GEMCITABINE (NSC#613327) PLUS G-CSF WITH PLACEBO IN THE
TREATMENT OF RECURRENT OR ADVANCED LEIOMYOSARCOMA OF THE UTERUS
PI: David G. Mutch, MD • Coordinator: Lynne Lippmann, CCRP -
Sponsored by Gynecologic Oncology Group (NCI), GOG 250 - Cooperative Group
This is a Phase III randomized, blinded, placebo controlled study with 2 arms: one arm involves the use of the combination
of docetaxel and gemcitabine, G-CSF and Bevacizumab versus the other arm utilizing the combination of docetaxel and
gemcitabine, G-CSF and placebo. Gemcitabine and docetaxel are the current commonly used drugs for the treatment of
leiomyosarcoma ad the use of Bevacizumab/placebo is the investigational portion of this study. If there is evidence of tumor
progression, the investigator may request information regarding whether or not Bevacizumab was part of the original treatment
regimen. Gemcitabine is given on Day 1 of a 21 day cycle along with the Bevacizumab/placebo. On day 8 patients receive
docetaxel and gemcitabine. All drugs are given intravenously. G-CSF is given after Day 8, either utilizing Neupogen daily for 7
days or Neulasta given on Day 9 or 10. There is a translational research component to this study involving tumor tissue taken
from a previous biopsy or surgery. Treatment will continue unless there is evidence of disease progression, there are side effects
prohibiting further therapy, or the study is stopped. Target accrual group-wide: 130