GYN/ONC Active Protocols

Tumor Site: CERVIX

 

Stage

Protocol

Description

Persistent or Recurrent

127V

PENDING

A Phase II Evaluation of ABI-OO7 in the TXof Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix   DRUG PROVIDED

 Advanced, Persistent or Recurrent 0076GGLimited Access Phase II Trial of Pemetrexed (Alimta) in Combination with Cisplatin in the TX of Advanced, Persistent, or Recurrent Carcinoma of the Cervix.  

Recurrent

222

Prospective Evaluation of Pelvic Exenteration in Patients with Recurrent Cervical Cancer

 

Tumor Site: CORPUS UTERUS/ADENOCARCINOMA and SARCOMA

 

Stage

Protocol

Description

Advanced, Persistent or Recurrent

87M

Temporary Closure

A Phase II Evaluation of Trabectedin (Yondelis, R27941, IND #75, 111) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas

Recurrent Metastatic

0188

Temporary

Closure

Phase II Study of Faslodex in Recurrent/Metastatic Endometrial Carcinoma (Faslodex 250mg intramuscularly per month.) Drug Provided.

Stage III & IV or Recurrent

209

A Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF vs Carboplatin/Paclitaxel in Patients with Stage III & IV or Recurrent Endometrial Cancer


224

A Randomized, controlled Phase II Evaluation of Megestrol (Megace) in Different Dose and Sequence in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) from a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Drug Provided

Recurrent or Persistent

229F

Temporary Closure

A Phase II Evaluation of VEGF-TRAP (AFLIBERCEPT, NSC #724770, IND #BB100137) in the TX of Recurrent or Persistent Endometrial Carcinoma Drug Provided

   
 Advanced, Persistent or Recurrent

 232C

 

 A Phase II Evaluation of Paclitaxel, Carboplatin and BSI-201 in the TX of Advanced, Persistent or Recurrent Uterine Carcinosarcoma Drug Provided

Tumor Site: FALLOPIAN TUBE


Stage

Protocol

Description

Recurrent/Persistent Platinum-Resistant

126R

OPEN

A Phase II Evaluation of Abraxane in the TX of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tub, or Primary Peritoneal Cancer (Abraxis BioScience, Inc. Study # ABX-005) Drug Provided.

Recurrent

213

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or In Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. Drug Provided

Longitudinal Study, while on chemotherapy TX

235

A Prospective, Longitudinal Study of YKL-40 in Patients with FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy




Tumor Site: OVARY


Stage

Protocol

Description

Advanced

 NON-GOG Genetech, AVF3953s/OU

 Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer Drug Provided

Recurrent/Persistent Platinum-Resistant

126R

OPEN

A Phase II Evaluation of Abraxane in the TX of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tub, or Primary Peritoneal Cancer (Abraxis BioScience, Inc. Study # ABX-005) Drug Provided.

Recurrent or Persistent

    186F

Temporary Closure

 A Phase Ii Evaluation of Mifepristone in TX of Recurrent or Persistent Epithelial Ovarian , Fallopian Tube or Primary  Peritoneal Ca. Drug Provided

Primary/Recurrent

Stromal Tumors

Primary or Second-Line Therapy 1Prior Therapy

187


Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy.

Advanced Ovarian or Primary Peritoneal Who Achieve a Complete Response to Primary Platinum/Taxane Chemo

212

A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103), Versus NO TX Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Ca Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy. Drug Provided.

Recurrent

213

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or In Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. Drug Provided

Women who choose to undergo risk-reducing surgery.

215

A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Risk-Reducing Surgery that Results in the Removal of Both Ovaries Drug Provided.

Newly Diagnosed, Previously Untreated, Suboptimal Advanced

218

 

 

 

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel plus Concurrent Bevacizumab (RHUMAB VEGF, NSC 704865, IND 7921) Followed by Placebo, versus Carboplatin and Paclitaxel Pus Concurrent and Extended Bevacizumab, in Women with Newly diagnosed, Previously Untreated, Suboptimal Advance Stage Epithelial Ovarian and Peritoneal Primary Cancer Drug Provided

Longitudinal Study, while on chemotherapy TX

235

A Prospective, Longitudinal Study of YKL-40 in Patients with FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy

 Recurrent Low-Grade Serous

 239

Temporary
Closure

 A Phase II Trial of AZD6244 in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary

Drug and Captisol supplied by NCI




Tumor Site: PRIMARY PERITONEAL


Stage

Protocol

Description

 Advanced NON-GOG, Genetech, AVF3953/OU Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer Avastin Provided

Recurrent/Persistent Platinum-Resistant

126R

OPEN

 

A Phase II Evaluation of Abraxane in the TX of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tub, or Primary Peritoneal Cancer (Abraxis BioScience, Inc. Study # ABX-005) Drug Provided.

Recurrent or Persistent

    186F

Temporary Closure

 A Phase Ii Evaluation of Docetaxel Plus Trabectedin with Growth Factor Support in the Third Line TX of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal CA. Drug Provided

Advanced Ovarian or Primary Peritoneal Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

212

A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103), Versus NO TX Until Documented Relapse in Women with Advance Ovarian or Primary Peritoneal Cancer Who Achieve a complete Clinical Response to Primary Platinum/Taxane Chemotherapy. Drug Provided.

Recurrent

213

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or In Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. Drug Provided

Newly Diagnosed, Previously Untreated, Suboptimal Advanced

218

 

 

 

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel plus Concurrent Bevacizumab (RHUMAB VEGF, NSC 704865, IND 7921) Followed by Placebo, versus Carboplatin and Paclitaxel Pus Concurrent and Extended Bevacizumab, in Women with Newly diagnosed, Previously Untreated, Suboptimal Advance Stage Epithelial Ovarian and Peritoneal Primary Cancer Drug Provided

Longitudinal Study, while on chemotherapy TX

235

A Prospective, Longitudinal Study of YKL-40 in Patients with FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy








Tumor Site: TROPHOBLASTIC NEOPLASIA


Stage

Protocol

Description

Persistent

242

A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia



Tumor Site: VULVA/VAGINA


Stage

Protocol

Description

No studies available.

 





Tumor Site: BENIGN


Stage

Protocol

Description

No studies available.