Adult Clinical Trials

Gynecological Cancers - Ovarian cancer and cancers of the female organs

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact the Gynecology (GYN) Clinical Trials Office at 919.555.3780.

17 trials identified.

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination with Bevacizumab Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Fallopian Tube and Peritoneal Primary Cancer
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.
Reference Number: 00007487
View this trial at ClinicalTrials.gov

Cervical Cancer Detection Using Optical Spectroscopy
Phase: N/A
Sponsor: PI initiated
Principal Investigator: Nimmi Ramanujam
Contact: Marlee Junker
Phone: 919.660.8446
Purpose: The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Reference Number: 00008173
View this trial at ClinicalTrials.gov

Tissue and Data Acquisition Activity for the Study of Gynecologic Disease
Phase: Other
Sponsor: Federal Government initiated
Principal Investigator: Laura Havrilesky
Contact: Debra Davis, RN
Phone: 919.684.6125
Purpose: The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.
Reference Number: 00013703
View this trial at ClinicalTrials.gov

GOG 0264: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. BLeomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of The Ovary
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.
Reference Number: 00022731
View this trial at ClinicalTrials.gov

A Randomized Phase II Evaluation of Carboplatin/Paclitaxel with and without Trastuzumab (Herceptin) in HER2/neu+ Patients with Advanced/Recurrent Uterine Serous Papillary Carcinoma
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Laura Havrilesky
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).
Reference Number: 00032751
View this trial at ClinicalTrials.gov

A Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Phase: Phase II
Sponsor: PI initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: The main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months.
Reference Number: 00033060
View this trial at ClinicalTrials.gov

A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Angeles Secord
Contact: Gynecology Oncology Clinical Research Office
Phone: 919.684.3780
Purpose: Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.
Reference Number: 00039020
View this trial at ClinicalTrials.gov

GOG 0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Progression-Free Survival
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Laura Havrilesky
Contact: Jessie Ehrisman
Phone: 919.684.9065
Purpose: This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
Reference Number: 00039076
View this trial at ClinicalTrials.gov

GOG 0281: A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials Office
Phone: 919.684.3780
Purpose: This randomized phase II/III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen citrate, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or topotecan hydrochloride in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.
Reference Number: 00048471
View this trial at ClinicalTrials.gov

GOG 0286B: A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
Reference Number: 00049306
View this trial at ClinicalTrials.gov

S1316: Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYN Oncology Clinical Trials
Phone: 919.684.3780
Purpose: This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.
Reference Number: 00058895
View this trial at ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy (VITAL)
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Brittany Davidson
Contact: GYNECOLOGY ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.684.3780
Purpose: This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will manufactured. Subjects will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.
Reference Number: 00058896
View this trial at ClinicalTrials.gov

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Chemotherapy Regimens
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Angeles Secord
Contact: Gynecology Oncology Clinical Research Office
Phone: 919.684.3780
Purpose: This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
Reference Number: 00062414
View this trial at ClinicalTrials.gov

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer (CORAIL Trial)
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Stephanie Gaillard
Contact: GYNECOLOGY ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.684.3780
Purpose: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
Reference Number: 00062433
View this trial at ClinicalTrials.gov

A Phase 3 Placebo-controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian Fallopian Tube, or Primary Peritoneal Cancer
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Angeles Secord
Contact: GYNECOLOGY ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.684.3780
Purpose: The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Reference Number: 00063539
View this trial at ClinicalTrials.gov

NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYNECOLOGY ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.684.3780
Purpose: This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.
Reference Number: 00070645
View this trial at ClinicalTrials.gov

NRG-GY004: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Angeles Secord
Contact: GYNECOLOGY ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.684.3780
Purpose: This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Reference Number: 00070659
View this trial at ClinicalTrials.gov