Ovarian Cancer

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OVARIAN CANCER

General Purpose:

The ovaries are almond-sized organs that are part of a female’s reproductive system. They release eggs for the purposes of reproduction, and are also responsible for the production of two key hormones – estrogen and progesterone. Like all other parts of the body, the ovaries can also be affected by cancer.

It is estimated that in 2012, over 22,000 new cases of ovarian cancer will be diagnosed and over 15,000 deaths due to ovarian cancer will occur. Ovarian cancer is more common among women with a family history of the disease, those who are over the age of 55, and those who have a personal history of cancer (especially cancer of the breast, uterus, colon, or rectum).

In addition, women who have never been pregnant, as well as women who have a history of hormone therapy, are also at an increased risk of ovarian cancer. Some symptoms of ovarian cancer include abdominal pressure or pain, as well as pain in the pelvis, back or legs. Abdominal swelling may also occur, as well as nausea, indigestion, constipation, or diarrhea. Ovarian cancer may also result in extreme fatigue.

Unfortunately, ovarian cancers are often diagnosed when they are in the later stages of development, due to their non-specific symptoms and the fact that they can grow for some time before symptoms ever become noticeable. Ovarian cancers are usually treated with a combination of surgery and chemotherapy; radiation therapy is not routinely used.

Ovarian cancer research is currently focused on a number of aspects related to the disease. Research into the genetic causes of ovarian cancer is gaining speed, as scientists look to gain a better understanding of how various genes involved with ovarian cancer lead to its development.

The information gained from such studies is helping to fuel additional studies that seek to develop better methods for screening women who are at an increased risk of developing ovarian cancer due to their family history or certain genetic factors. Relatedly, some studies are testing new drugs to see if they can help prevent ovarian cancer from occurring among high-risk women.

Finally, new treatments are constantly being tested, including new combinations of chemotherapy designed for women whose cancers have become resistant to the effects of standard chemotherapy drugs.

What Will Ovarian Cancer Clinical Trials Be Like?

Ovarian cancer clinical trials may involve many common tests and procedures; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Examples of specific tests and procedures that may be used in a clinical trial for ovarian cancer include the following:

  • Physical exam and detailed family history information
  • Pelvic exam
  • Pap smear
  • Blood and/or tissue sample for the purposes of conducting genetic testing
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Imaging procedures such computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.   
  • Colonoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is inserted through the rectum into the intestines. This test can help to identify if ovarian cancer has spread to the colon and/or rectum.
  • Chest x-ray to identify lung metastases
  • Abdominal or vaginal ultrasound
  • Surgery
  • Biopsy
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
  • Pain assessments

Typical Ovarian Cancer Clinical Trial Protocol:

There is a variety of research currently being conducted for women with ovarian cancer. Sample clinical trials might include the following:

  • A clinical trial in which patients with ovarian cancer are randomly assigned to receive standard chemotherapy combined with a newly-developed immunotherapy drug (a drug that works with the body’s natural immune system to attack cancer cells) or standard chemotherapy plus a placebo.
  • A clinical trial to determine the effectiveness of an ovarian cancer vaccine in healthy women with a family history of ovarian cancer and a specific genetic mutation known to be associated with an increased risk of ovarian cancer.
  • A clinical trial designed to evaluate if long-term use of hormonal contraceptives (e.g., birth control pills) is associated with an increased risk of ovarian cancer.
  • A study to evaluate genetic mutations in ovarian cancers and determine if the presence of certain mutations indicate a more favorable response to a particular chemotherapy drug.
  • A study to determine which type of surgical method used to remove the ovaries and fallopian tubes leads to the fewest side effects for patients.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the first clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however, it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms:

 “ovarian cancer treatment,” “ovarian cancer chemotherapy,” “ovarian cancer management,” “ovarian cancer surgery,” “advanced ovarian cancer,” “ovarian cancer vaccine,” “ovarian cancer screening,” “ovarian cancer pediatric,” and “ovarian cancer genetics.”

 

Current Search Term:

“Ovarian Cancer”

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Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Fostamatinib and Paclitaxel
Sponsors:   Sidney Kimmel Comprehensive Cancer Center;   Rigel Pharmaceuticals
Not yet recruiting


Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA


Condition:   Ovarian Cancer
Intervention:  
Sponsor:   AstraZeneca
Recruiting


Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology


Condition:   Ovarian Cancer
Intervention:   Device: Caiman® device
Sponsor:   Catholic University of the Sacred Heart
Enrolling by invitation


Intervention of IgT Against Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Biological: OC-IgT cells
Sponsor:   Shenzhen Geno-Immune Medical Institute
Recruiting


Phase Ib Study of Chiauranib in Patients With Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Chiauranib
Sponsor:   Chipscreen Biosciences, Ltd.
Not yet recruiting


Genes Contributing to Hereditary Ovarian Cancer in African American Women and BRCA1/2 Wildtype Families


Condition:   Ovarian Cancer
Intervention:  
Sponsor:   University of Washington
Recruiting


The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients


Condition:   Ovarian Cancer
Intervention:  
Sponsor:   National Taiwan University Hospital
Recruiting


A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer


Condition:   Ovarian Cancer
Interventions:   Drug: Pembrolizumab;   Drug: Gemcitabine;   Drug: Cisplatin
Sponsors:   Cedars-Sinai Medical Center;   Merck Sharp & Dohme Corp.
Recruiting


Writing About Experiences With Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Behavioral: Writing about ovarian cancer
Sponsor:   University of Maryland
Completed


Cabazitaxel vs. Tocotrienol in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.


Condition:   Ovarian Cancer
Interventions:   Drug: Cabazitaxel;   Drug: Tocotrienol
Sponsor:   Vejle Hospital
Recruiting


Ovarian Cancer Patient-Centered Decision Aid


Condition:   Stage III Ovarian Cancer
Intervention:   Other: Decision Aid
Sponsors:   University of California, Irvine;   Patient-Centered Outcomes Research Institute
Unknown status


Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: OMP-54F28, Paclitaxel and Carboplatin
Sponsor:   OncoMed Pharmaceuticals, Inc.
Active, not recruiting


Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)


Condition:   Ovarian Cancer
Intervention:   Drug: IMAB027
Sponsor:   Ganymed Pharmaceuticals GmbH
Completed


Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment


Conditions:   Recurrent Ovarian Cancer;   Platinum Sensitive Ovarian Cancer
Intervention:   Drug: Carboplatin
Sponsor:   Massachusetts General Hospital
Terminated


Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer


Condition:   Ovarian Cancer
Interventions:   Drug: Pimasertib once daily;   Drug: Pimasertib placebo;   Drug: SAR245409 placebo;   Drug: SAR245409;   Drug: Pimasertib twice daily
Sponsors:   EMD Serono;   Sanofi
Active, not recruiting


SGI-110 in Combination With Carboplatin in Ovarian Cancer


Condition:   Ovarian Cancer
Interventions:   Drug: SGI-110 and carboplatin;   Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)
Sponsor:   Astex Pharmaceuticals
Completed


Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study


Condition:   Ovarian Cancer
Intervention:  
Sponsor:   University of Washington
Active, not recruiting


Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Azacitidine
Sponsors:   Loyola University;   Celgene Corporation
Withdrawn


Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Biological: BC-819
Sponsor:   BioCancell Ltd.
Completed


An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer


Condition:   Ovarian Cancer
Interventions:   Drug: MORAb-003 (farletuzumab);   Drug: 0.9% Saline;   Drug: Paclitaxel
Sponsor:   Morphotek
Terminated


A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Lovastatin and Paclitaxel
Sponsor:   University of Iowa
Unknown status


Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function


Condition:   Ovarian Cancer
Intervention:   Behavioral: Fertility-Sparing Survey
Sponsors:   Dana-Farber Cancer Institute;   Beth Israel Deaconess Medical Center;   Brigham and Women's Hospital;   Massachusetts General Hospital
Completed


MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer


Condition:   Ovarian Cancer
Interventions:   Drug: liposomal doxorubicin;   Drug: carboplatin;   Drug: paclitaxel
Sponsor:   National Cancer Institute, Naples
Active, not recruiting


Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Ispinesib
Sponsor:   GlaxoSmithKline
Completed


A Study to Evaluate the Effect of HER2 Activation on rhuMAb 2C4 (Pertuzumab) in Subjects With Advanced Ovarian Cancer


Condition:   Ovarian Cancer
Intervention:   Drug: Pertuzumab (rhuMAb 2C4)
Sponsor:   Genentech, Inc.
Completed

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