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Ovarian Clinical Trials


Genentech YO39523

A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Cynthia Evancho, RN, BS

  • Treatment Agent: Atezolizumab, Bevacizumab

    Synopsis: You are invited to take part in a research study (also known as a clinical trial) of a drug called TECENTRIQTM (atezolizumab). You were selected as a possible participant in this study because you have Stage III or Stage IV ovarian, fallopian tube, or primary peritoneal cancer with tumors left after surgery that tried to remove all of your cancer or you are receiving chemotherapy before having the surgery to remove all of your tumor.

    The purpose of this study is to research the effects, good or bad, of atezolizumab on your specific type of cancer (ovarian, fallopian tube, or primary peritoneal). Atezolizumab is a type of drug called a programmed deathligand 1 (PD-L1) antagonist. It is an experimental drug, which means that the health authorities have not approved atezolizumab for the treatment of your specific type of cancer. However, atezolizumab is approved in the United States (U.S.) for the treatment of locally advanced or metastatic bladder cancer (urothelial carcinoma) that came back after getting platinum-containing chemotherapy. Atezolizumab is also approved in the U.S. for patients with non-small cell lung cancer whose cancer came back after getting either platinum-containing chemotherapy and/or a targeted therapy against their specific type of lung cancer.

    Atezolizumab is an antibody that affects your immune system by blocking the PD L1 pathway. An antibody is a large, Y-shaped protein used by your body’s immune system to identify and kill foreign objects, such as bacteria, viruses, and tumor cells. The PD L1 pathway is involved in the decrease of your body’s natural immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help your immune system to stop or reverse the growth of tumors.

    In this study, you will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy based treatments are standard for patients with your specific type of cancer. In addition to these standard treatments, you will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

    Blood, tissue, and fluid samples, and related medical information collected during this study will be used by the Sponsor’s researchers and their partners to learn more about how atezolizumab affects your specific type of cancer. 

    • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • Life expectancy greater than (>) 12 weeks
    • For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
    • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)
    • Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
    • Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
    • Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
    • Received prior radiotherapy to any portion of the abdominal cavity or pelvis
    • Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
    • Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
    • Have synchronous primary endometrial cancer
    • Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
    • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
    • Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
    • Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery
    • Have prior allogeneic bone marrow transplantation or solid organ transplant
    • Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
    • Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
      Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
    • Have core biopsy or other minor surgical procedures, that exclude the placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
    • Have known sensitivity to any component of bevacizumab
    • Have known sensitivity to any component of paclitaxel

GOG 0225

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

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Cynthia Evancho, RN, MBA, BS

  • Treatment Agent: N/A

    Synopsis: The purpose of this study is to find out if a change in diet and exercise in women with Ovarian Fallopian Tube and Primary Peritoneal Cancer has an effect on the length of time you are cancer free following initial treatment. Some studies suggest diet and exercise may improve survival for cancer patients, but no studies have been done to show if changes in diet and exercise can have an effect on cancer returning in women treated for ovarian, fallopian tube, or primary peritoneal cancer. Other goals include finding out if the changes in diet and exercise will improve your overall quality of life and your ability to be physically active. In addition, you may be asked if researchers can test some of your blood to measure carotenoid levels, which will tell them about the kind of foods you are eating, and examine your genes (DNA).

    • Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
    • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma
    • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy or biological therapy
    • Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
    • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
    • Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
    • Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
    • Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization (previous 12 months)
    • Patients must complete all pre-entry assessments
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information
    • Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC
    • Patients with GOG performance grade of 3 or 4
    • Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus
    • Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
    • Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
    • Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
    • Patients with a life expectancy of less than one year
    • Patients with Body Mass Index (BMI) < 20 kg/m^2
    • Vegan vegetarians
    • Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
    • Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
    • Patients who have had surgery for weight loss


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)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Cynthia Evancho, RN, MBA, BS

  • Treatment Agent: Cediranib, Olaparib

    Synopsis: This study has two parts: A Phase II part and a Phase III part. You are being asked to participate in the Phase III part of the study. The purpose of the Phase II part of the study is to compare any good and bad effects of using a combination of the experimental drugs cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone. The Phase III study will follow the Phase II to confirm the effectiveness of a combination of cediranib and olaparib to the standard chemotherapy. One of the experimental drugs, either cediranib or olaparib alone may be compared with the standard chemotherapy for the effectiveness, after reviewing the results from Phase II study. Cediranib is an experimental drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. Olaparib by itself has been approved by the Food and Drug Administration (FDA) for use in women with advanced ovarian cancer with BRCA1 and BRCA2 mutations (defined below) who have been treated with three or more different chemotherapy treatments. The combination of olaparib and cediranib is investigational. These drugs have been used in other research studies in ovarian cancer, and information from those other research studies suggest that these may help to keep cancer from growing. The addition of cediranib to olaparib could shrink your cancer but it could also cause side effects. This study will allow the researchers to know whether this different approach using two study drugs is better, the same, or worse than the usual chemotherapy approach. Standard chemotherapy drugs that are already FDA-approved for use in recurrent ovarian cancer include paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD).

    Another purpose of this study is for researchers to learn if a biomarker test is helpful to decide whether or not a patient’s tumor will respond to the study drug(s). Tissue from your surgery will be used for the biomarker test. Extra tubes of blood will also be drawn for the biomarker test. Researchers do not know if using the biomarker test is better, the same, or worse than if you enrolled in this study without using the biomarker test.

    The biomarker test will be done to study gene mutations using a sample from the tissue that was collected at the time of your surgery or biopsy and from a blood sample collected before you start treatment. Also, two additional blood samples will be collected before and three days after you begin treatment to study changes in cells that have been shed from the lining of the vascular wall into the blood stream related to blood vessel injury, and to investigate proteins related to tumor growth, blood vessel formation and inflammation.

    • Patients must 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; participants with a deleterious germline BRCA-mutation on a commercial Clinical Laboratory Improvement Amendments (CLIA) assay with other high-grade histologies, including mucinous adenocarcinoma, clear cell, transitional cell, undifferentiated adenoca, undifferentiated carcinoma, mixed epithelial andenoca are also eligible
    • Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy
    • Phase II study: measurable disease by RECIST 1.1 criteria; baseline biopsy for retinitis pigmentosa 2 (RP2) study is optional but highly encouraged
    • Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen (CA)125 >= 2 x upper limit of normal [ULN])
    • No more than 2 prior treatment regimens (including primary therapy); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit
    • Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
    • Patient must have provided study specific informed consent prior to study entry
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    • Absolute neutrophil count > 1,500/mcL
    • Platelets > 100,000/mcL
    • Hemoglobin > 10 g/dL
    • Total bilirubin within 1.5 times the upper limit of normal (ULN) institutional limits
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional ULN
    • Creatinine < the institutional ULN or creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal
    • Less than or equal to 1+ proteinuria on two consecutive dipsticks taken no less than 1 week apart, or < 1 gm protein on 24-hour urine collection or a urine protein:creatinine ratio of < 1
    • Troponin T or I within normal institutional limits
    • Coagulation parameters (international normalized ration [INR], activated partial thromboplastin time [aPTT]) within 1.25 x ULN institutional limits
    • Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v4.0; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall Principal Investigator (PI)
    • Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients who are on three antihypertensive medications must be actively followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings
    • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits
    • Patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; subjects with early-stage cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible
    • Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities; these patients should have increased monitoring: 1) prior treatment with anthracyclines, 2) prior treatment with trastuzumab, 3) a New York Heart Association classification of II controlled with treatment, 4) prior central thoracic radiation therapy (RT), including RT to the heart, 5) history of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
    • Able to tolerate oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib
    • Chemotherapy or radiation therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C); patients must have recovered from adverse events due to agents administered more than 3 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study
    • Any other investigational agents within the past 4 weeks
    • Prior use of poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitors; prior treatment affecting the vascular endothelial growth factor (VEGF) pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, and nintedanib; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
    • CA-125 only disease
    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
    • Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs except temporary (< 24 hr) improved with medical management within last 3 months
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
    • Dependency on IV hydration or total parenteral nutrition (TPN)
    • Current pregnancy; patients must be on two forms of birth control if of child-bearing potential
    • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
    • Patients with any of the following:
      • History of myocardial infarction within six months
      • Unstable angina
      • Patients with corrected QT interval (QTc) prolongation > 470 msec (with Bazett's correction) or familial long QT syndrome
      • New York Heart Association functional classification of III or IV
    • If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
      • Patients with the following risk factors should have a baseline cardiac function assessment:
        • Prior treatment with anthracyclines
        • Prior treatment with trastuzumab
        • Prior central thoracic radiation therapy (RT), including RT to the heart
        • History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)
        • Prior history of impaired cardiac function
    • History of stroke or transient ischemic attack within six months
    • Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)
    • Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted
    • Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
    • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Known human immunodeficiency virus (HIV)-positive individuals are ineligible
    • Patients may not use natural herbal products or other "folk remedies" while participating in this study