Ongoing Clinical Trials Actively Recruiting Patients With Ovarian or Cervical Cancers

Study Title: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study

Study Sponsor and Collaborators: Northwestern University, National Cancer Institute

Purpose: To improve strategies for detection and prevention of early-stage disease. This study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high-risk population and those who have the ­disease.

Ages Eligible for Study: 18 to 80 years

Genders Eligible for Study: Female

Accepts Healthy Volunteers: No

Primary Outcome Measures: The identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecologic malignancies (time frame: outcomes will be assessed at the completion of the study).

Principal Investigator: Lee P. Shulman, MD, Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 312-695-1301; cancer@northwestern.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00005095

Study Title: Worry, Uncertainty, and Insomnia: A Cognitive-Behavioral Intervention for Cancer Survivors

Study Sponsor and Collaborators: Ohio State University Comprehensive Cancer Center, American Cancer Society, the Lance Armstrong Foundation

Purpose: This clinical trial is investigating cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study is also exploring the neuroimmunologic correlates of anxiety and ­insomnia.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Changes in worry on the Penn State Worry Questionnaire; changes in sleep efficiency on the Insomnia Severity Index; changes in intolerance of uncertainty on the Intolerance of Uncertainty Scale (time frame: from baseline to 6 weeks).

Principal Investigator: Sharla Wells-Di Gregorio, PhD, Ohio State University Comprehensive Cancer Center; 866-627-7616; sharla.wells@osumc.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01929720

Study Title: A Phase I Study of Carboplatin and Gemcitabine and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer

Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute

Purpose: 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. To determine this maximum tolerated dose, patients will receive different amounts of carboplatin and gemcitabine.

Ages Eligible for Study: 19 years and older

Genders Eligible for Study: Female

Accepts Healthy Volunteers: No

Primary Outcome Measures: Rate of acute grade 3–5 toxicities following carboplatin/gemcitabine hydrochloride and stereotactic body radiation therapy graded based on Common Terminology Criteria for Adverse Events, version 4.0 (time frame: within 30 days of completing treatment).

Principal Investigator: Steven Waggoner, MD, Case Comprehensive Cancer Center; 216-844-5011; steven.waggoner@uhhospitals.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01652794

Study Title: A Phase I Study of Vorinostat in Combination With Paclitaxel and Carboplatin in Solid Tumors (With Focus on Upper Aerodigestive Cancers) in Persons With HIV Infection

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and the best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with metastatic or recurrent solid tumors, including recurrent ovarian epithelial cancer, and HIV infection. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Incidence of adverse events during paclitaxel and carboplatin treatment according to dose-limiting toxicities, graded using Common Terminology Criteria for Adverse Events, version 4.0 (time frame: 21 days).

Principal Investigator: Missak Haigentz, MD, AIDS Associated Malignancies Clinical Trials Consortium; 718-920-4826; mhaigent@montefiore.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01249443

Study Title: A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Study Sponsor and Collaborators: Ohio State University Comprehensive Cancer Center, National Cancer Institute

Purpose: To study stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

Ages Eligible for Study: 21 to 85 years

Genders Eligible for Study: Female

Accepts Healthy Volunteers: No

Primary Outcome Measures: Quality of life as assessed by Short Form-36 (time frame: up to 28 weeks).

Principal Investigator: Barbara Anderson, PhD, Ohio State University Comprehensive Center; 614-292-4236; Andersen.1@osu.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01764789

Study Title: A Randomized Trial of a Family Caregiver Palliative Care Intervention

Study Sponsor and Collaborators: City of Hope Medical Center, National Cancer Institute

Purpose: To study the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II/IV gastrointestinal, gynecologic, and urologic cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of patients with cancer.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

Primary Outcome Measures: The effects of Family Caregiver Palliative Care Intervention on caregiver burden (time frame: up to 6 months).

Principal Investigator: Betty Ferrell, PhD, City of Hope Medical Center; 800-826-4673; bferrell@coh.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01846520