CLINICAL TRIAL SUMMARY

MDACC Study No:GOG 0213 (clinicaltrials.gov NCT No: NCT00565851)
Title: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 Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary, and Fallopian Tube Cancer. NCI-Supplied Agent: Bevacizumb (NSC #704865, IND #113912)
Principal Investigator:Robert Coleman
Treatment Agent:Bevacizumab; Carboplatin; Paclitaxel; Surgical Procedure
Study Status:Open
Study Description:The main goal of this clinical research study is to learn if a second surgery
to remove tumor tissue, followed by chemotherapy, can help patients to stay
disease-free longer.

Researchers would also like to compare the combination of carboplatin,
paclitaxel, and bevacizumab to the standard combination of carboplatin and
paclitaxel alone or carboplatin and gemcitabine alone, in treating ovarian,
primary peritoneal, or Fallopian tube cancer.

Hide details for General InformationGeneral Information

Disease Group:Fallopian Tube; Ovary; Peritoneum
Phase of Study:Phase III
Treatment Agents:Bevacizumab
Carboplatin
Paclitaxel
Surgical Procedure
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:One 3-5 day hospital stay for surgery.
Supported By:Genentech provides agent which is distributed via the National Cancer Institute
Gynecologic Oncology Group
Return Visit:1 pre-surgery visit (eligible pts only)
1 pre-chemotx visit
treatment: every 21 days until disease progression, toxicity precludes further
treatment or pt refuses treatment
post treatment: every 3 months for 2 years, then every 6 months for 10 years
Home Care:none


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Robert Coleman
Dept:Gynecologic Oncology
For Clinical Trial Enrollment:713-745-3357
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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