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|Protocol||Trial Name and Objective|
GOG-0213: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitibine) alone or in Combination with Bevacizumab (NSC # 704865, IND # 7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer
One purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning). A second purpose of this study is to determine if a second surgery to remove the tumor followed by chemotherapy can increase the time that the subject remains disease free. If the study doctor feels that the subject is a good candidate for the second surgery the subject will be randomized to have surgery or not and at the same time the subject will be randomized to receive one of the two possible chemotherapy combinations.
GOG 0261: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin versus Ifosfamide plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
The primary objective of this study is to determine if treatment with combination paclitaxel and carboplatin chemotherapy results in improved survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy.
NSABP PROTOCOL B-49:A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-RiskNode-Negative, HER2-Negative Breast Cancer
Primary Aim: Aim: To determine if the docetaxel plus cyclophosphamide regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (IDFS) by combining B-49 data with the TAC and TC arms of NSABP B-46-I/USOR 07132 and the data from USOR 06-090.
M13-695: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects with Solid Tumors
Assess and compare the bioavailability of three test extended release (ER) formulations of veliparib with that of the current imemdiate release formulation of veliparib. Evaluate the potential effect of food on the oral bioavailability of three test extended release (ER) formulations of veliparib. Establish the maximum tolerated dose (MTD) and to establish the recommended Phase 2 dose (RPTD) and schedule for one or more of the ER formulations. Secondary objectives of the study are to assess the safety and tolerability of the ER formulations.
Psychological Interventions for Gynecologic Cancer
Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.
GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube And Primary Peritoneal Cancer Progression-Free Survival?