Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Invasive Epithelial Ovarian CancerPrimary Peritoneal Carcinoma1 moreThis research is looking at the effect of biobehavioral factors such as stress and whether these factors alter how the body responds to chemotherapy, one of the purposes of this study is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer. An additional purpose of the study is to understand if behavioral factors such as depression and anxiety can alter different blood markers that affect tumor vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such as Inderal, might alter these behavioral factors by drawing blood prior to and after the administration of Inderal as well as giving behavioral questionaires at different time points. Beta-blockers are commonly used for the treatment of hypertension, protection of the heart after a heart attack, and irregularities in heartbeats. Altering these factors might boost the immune system and affect other areas of cancer biology, thereby allowing the chemotherapy to be more effective. The significance of this research is that it may help improve our treatments of this disease in the future.
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Ovarian DiseasesOvarian NeoplasmsThe main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel...
Ovarian CancerThis is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation. In Part 1, a small group of participants will receive adavosertib along with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this combination. In Part 2, participants will be randomly assigned to receive either adavosertib plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of adavosertib compared to placebo. The primary hypothesis of the study (Part 2) is that administration of adavosertib in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin alone.
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
Bulky Stage IIIC and IV Epithelial Ovarian CancerFallopian Tube Cancer1 moreThe purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological...
Leydig Cell TumorOvarian Sarcoma11 moreThe purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.
CART-meso in Mesothelin Expressing Cancers
Metastatic Pancreatic (Ductal) AdenocarcinomaEpithelial Ovarian Cancer1 morePhase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.
Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With...
Ovarian CancerThis is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL • min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and carboplatin will be given. Additional cycles may be given as per institutional standard of care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg.
Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial...
Ovarian NeoplasmsOvarian Epithelial CancerThe purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Ovarian Epithelial Cancer RecurrentBioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .
Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients...
Ovarian CancerThis is a multi-center, single-dose, open-label, randomized, balanced, two-treatment, two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference (R) formulations of doxorubicin hydrochloride liposome injection in female patients with ovarian cancer. Each patient will be randomized to one of two treatment sequences (RT or TR) according to a randomization scheme prepared prior to the start of the trial.There will be at least 4-week apart between each single-dose administration. Serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will be obtained in each cycle. The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate bioequivalence.