A Phase III randomized controlled clinical trial of CARBOPLATIN and PACLITAXEL(OR GEMCITABINE) alone or in combination with BEVACIZUMAB (NSC #704865, IND #7921) followed by BEVACIZUMAB and secondary cytoredutive surgery in platinum sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer. - GOG-0213

Gynecologic Oncology Group0 sites1,050 target enrollmentJune 1, 2010

ConditionsPLATINUM-SENSITIVE, RECURRENT OVARIAN, PERITONEAL PRIMARY AND FALLOPIAN TUBE CANCER

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: PLATINUM-SENSITIVE, RECURRENT OVARIAN, PERITONEAL PRIMARY AND FALLOPIAN TUBE CANCER
Sponsor: Gynecologic Oncology Group
Enrollment: 1050
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 1, 2010

End Date

March 31, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Gynecologic Oncology Group

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\)More than 1 previous regimen of chemo 2\)Receiving concurrent immunotherapy or radiotherapy 3\)Prior radiotherapy to any portion of the abdominal cavity or pelvis 4\)Evidence of partial bowel obstruction or perforation 5\)Prior chemo for any abdominal or pelvic tumor 6\)Synchronous primary endometrial cancer, or a past history of primary endometrial cancer 7\)Secondary cytoreduction for recurrent disease 8\)Uncontrolled infection 9\)Concurrent severe medical problems unrelated to the malignancy 10\)More than grade2 peripheral neuropathy 11\)History of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds. 12\)Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. 13\)Childbearing potential, not practicing adequate contraception, pregnant or nursing 14\)Other invasive malignancies, with the exception of non\-melanoma skin cancer, within the last 5 yrs 15\)Active bleeding or pathologic conditions that carry high risk of bleeding 16\)History or evidence upon physical examination of CNS disease 17\)Significant cardiac conduction abnormalities 18\)Uncontrolled hypertension, defined as systolic \>150mmHg or diastolic \>90mmHg 19\)Myocardial infarction, cardiac arrhythmia or unstable angina \< 6mo prior to registration 20\)NYHA Grade2 or greater congestive heart failure 21\)Serious cardiac arrhythmia requiring medication 22\)Grade2 or greater peripheral vascular disease 23\)History of CVA within 6mo 24\)Patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28days prior to the treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7days prior to the treatment on this study.