Gynecologic Cancer Clinical Trials

California Pacific CURRENTS: The online journal of CPMC Research Institute

Cervical Cancer

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Description: Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with pathologically confirmed primary cervical cancer initially treated with a standard radical hysterectomy with pelvic lymphadenectomy

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Description: This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer.

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent.

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 Cervical Cancer

Description: Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade

Status

Active and open to enrollment

Christina Nguyen, 415-600-1781

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Description: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

 

Endometrial Cancer

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

Description: Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with a histologically confirmed diagnosis of endometrial cancer and who must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

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

Description: Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma

Status

Contact site for study status

Contacts

Isheen Herrera, 415-600-3619

 

Ovarian Cancer

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

Description: 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.

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

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

Description: 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

Investigators

Eligibility Requirements

Females, 18 years and older, with a histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)

Description: 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

Investigators

Eligibility Requirements

Females, 18 years and older, with a confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

 

A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum

Description: This phase II trial studies how well cabozantinib-s-malate works in treating patients with ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is growing, spreading, or getting worse

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with recurrent or, progressive clear cell ovarian cancer

Status

Contact site for study status

Contacts

Christina Nguyen, 415-600-1781

 

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens

Description: 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 at least three previous chemotherapy regimens

Investigators

Eligibility Requirements

Females, 18 years and older, with histologically diagnosed recurrent high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

 

Double-Blind, Placebo Controlled, Phase III Trial of FANG TM (Adjuvant bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) for High Risk Stage III/IV Ovarian Cancer

Description: A multicenter, randomized, double-blind, placebo-controlled, Phase III study of maintenance FANG in women with Stages III/IV high-grade serous / endometrioid ovarian, fallopian tube or primary peritoneal cancer who have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.

Investigators

Eligibility Requirements

Females, 18 years and older, with histologically confirmed Stage III/IV high-grade serous / endometrioid ovarian, fallopian tube or primary peritoneal cancer without prior therapy

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

 

Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?

Description: Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

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

Description: Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, with documented low-grade serous carcinoma; confirmation must occur by prospective pathology review prior to study entry; the prospective pathology review must be done on tissue from the recurrent carcinoma

Status

Contact site for study status

Contacts

Christina Nguyen, 415-600-1781

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)

Description: 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).

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

>Females, 18 years and older, who have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Description: This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally (PO) and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

Investigators

Eligibility Requirements

Females, 18 years and older, who have histologically documented, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619

Molecular Analysis for Therapy Choice (MATCH)

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

Females, 18 years and older, who have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and that has progressed following at least one line of standard systemic therapy and/or for whose disease no standard treatment exists that has been shown to prolong survival

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

A Phase III, Open Label, Randomized, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations

Description:Olaparib Treatment in Relapsed Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments. (SOLO3)

Investigators

Eligibility Requirements

Females, 18 years and older, with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer

Status

Active and open to enrollment

Contacts

Christina Nguyen, 415-600-1781

An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Description: This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally (PO) and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

Investigators

Eligibility Requirements

Females, 18 years and older, who have histologically documented, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit

Status

Active and open to enrollment

Contacts

Isheen Herrera, 415-600-3619