GYN/ONC Active Protocols

Tumor Site: CERVIX

 

Stage

Protocol

Description

Persistent or Recurrent

127V

 

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

 0076GG

Temporary Closure

Limited Access Phase II Trial of Pemetrexed (Alimta) in Combination with Cisplatin in the TX of Advanced, Persistent, or Recurrent Carcinoma of the Cervix.  
HPV-AGC

   237

 Comparative Analysis of CA-IX, p16, Proliferative Markers and Human Papilloma Virus (HPV) in the diagnosis of significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells
 Recurrent or Persistent    240 Randomized Phase III Trial of Cisplatin plus Paclitaxel with and without NCI-Supplied Bevacizumab versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel with and without NCI supplied Bevacizumab in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix

 

TUMOR SITE: Endometrial

 Stage

Protocol

Description

Advanced Endometrial Cancer

CA163196

Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Endometrial Cancer who have previously been treated with Chemotherapy.

 Stage II, IVA, IVB or Recurrent Endometrail Cancer

 0086P

 A 3 Arm Radomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab, Paclitaxel/Carboplatin/Temsirolimu and Ixabepilone/Carboplatin/Bevacizumab as Initial therapy
Recurrent or Persistent

229H 

 Phase II Evaluation of AZD6244 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
 Recurrent or Persistent

        248

Temporary Closure

 Randomized Phase II Trial of Temsirolimus or the Combination of Hormonal Therapy Plus Temsirolimus in Woment with Advanced, Persistent, or Recurrent Endometrial Carcinoma

 

Tumor Site: CORPUS UTERUS/ADENOCARCINOMA and SARCOMA

 

Tumor Site: FALLOPIAN TUBE


Stage

Protocol

Description

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

 Stage II and Stage III optimally debulked with no measurable disease 252 Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

 Recurrent or Persistent

 

 126T Phase II Evaluation of Belinostat and Carboplatin in the TX of Recurrent or Persistent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

 Platinum Resistant or Refractory Ovarian

 

 MORAB-003-003 Randomized Double-Blind Placebo Controlled Study of the Efficacy and Safety of MORAb-003 in Combination with Paclitaxel Therapy in subjects with Platinum Resistant or Refractory Relapsed Ovarian Cancer
 Platinum Sensitive Ovarian Cancer in First Relapse MORAb-003-004 Randomized Double Blind Placebo-Controlled Phase 3 Study to Assess Efficacy and Safety of Weekly Farletuzumab in combination with Carboplatin and Taxane in Subjects with Platinum-Sensitive Ovarian Cancer in First Relapse




Tumor Site: OVARY


Stage

Protocol

Description

 Recurrent or Persistent

 126T

 Phase II Evaluation of Belinostat and Carboplatin in the TX of Recurrent or Persistent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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

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

 251

Temporary Closure

 Phase II Trial of NCI-Supplied Bevacizumab for Recurrent Sex Cord Stromal Tumors of the Ovary
  Stage II and Stage III optimally debulked with no measurable disease 252 Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
 Persistent or Recurrent Clear Cell Ovarian Carcinoma 254 A Phase II Evaluation of SU11248 (Sunitinib Malate) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma




Tumor Site: PRIMARY PERITONEAL


Stage

Protocol

Description

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

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 or Persistent

 170M

Temporary Closure

 Phase Ii Evaluation of Dasatinib in the Tx or Persistent or Recurrent Epethelial Ovarian, Fallopian Tue or Primary Peritoneal Carcinoma.
 Persistent

 242

 

 Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia
 Stage II and Stage III optimally debulked with no measurable disease 252 Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

TUMOR SITE: Uterine

 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 or Advanced

 250

 Randomized Phase III Evaluation of Docetaxel and Gemcitabine Plus G-CSF with Bevacizumab Versus Docetaxel and Gemcitabine Plus G-CSF with Placebo in the Tx of Recurrent or Advanced Leiomyosarcom of the Uterus

First Line Therapy

 261

 Randomized Phase III Trial of Paclitaxel Plus Carboplatin vs Ifosfamide plus Paclitaxel in Chemotherapy Naive Patients
 Advanced, Persistent or Recurrent

 232C

Temporary Closure

 

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

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.