Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02923739|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Adenocarcinoma Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Fallopian Tube Undifferentiated Carcinoma Malignant Ovarian Brenner Tumor Ovarian Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Ovarian Undifferentiated Carcinoma Primary Peritoneal Serous Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Biological: Bevacizumab Biological: Emactuzumab Other: Laboratory Biomarker Analysis Drug: Paclitaxel Other: Pharmacological Study||Phase 2|
I. To evaluate the safety of administration of paclitaxel, bevacizumab and emactuzumab over 4 weeks. (Part 1) II. To compare the progression-free survival (PFS) of patients with stable disease following Part 2A randomized to paclitaxel plus bevacizumab or to paclitaxel, bevacizumab plus emactuzumab. (Part 2B)
I. To estimate the progression-free survival (PFS) of the treatment arms. II. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response criteria ("responders").
III. Objective response rate by RECIST only ("RECIST responders"). IV. Objective response rate by CA-125 response criteria only ("CA-125 responders").
V. Biological progression-free interval (PFIbio) by serum CA-125 assessed according to the Gynecologic Cancer Intergroup (GCIG) criteria.
VI. Overall survival (OS). VII. Safety and tolerability. VIII. To characterize the pharmacokinetics of bevacizumab and emactuzumab when administered in combination.
I. To assess the utility of surrogate biomarkers and the anti-tumor response to therapy with the combination treatment of bevacizumab and emactuzumab.
II. To assess tumor alterations by serial non-invasive imaging macrophage-specific imaging, ADC (apparent diffusion coefficient) for cellularity, and DCE (dynamic contrast enhanced) for vasculature.
Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unexpected toxicity. Patients with stable disease are randomized to 1 of 2 arms.
ARM I: Patients receive paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive paclitaxel and bevacizumab as in Arm I. Patients also receive emactuzumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Induction Discontinuation Trial of Emactuzumab Following Paclitaxel and Bevacizumab in Patients With Platinum-Resistant, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||May 31, 2025|
|Estimated Study Completion Date :||May 31, 2025|
Active Comparator: Arm I (paclitaxel, bevacizumab)
Patients receive paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Experimental: Arm II (paclitaxel, bevacizumab, emactuzumab)
Patients receive paclitaxel and bevacizumab as in Arm I. Patients also receive emactuzumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Incidence of grade 3 or higher adverse events in 9 patients enrolled in Part I [ Time Frame: Up to 4 weeks ]Safety is defined as no required dose alterations during the first cycle (4 weeks) of therapy due to a grade 3 or greater related adverse event.
- Progression-free survival (Part IIB) [ Time Frame: At 32 weeks ]Will use a log-rank test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923739
|United States, New Jersey|
|MD Anderson Cancer Center at Cooper-Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|UT Southwestern/Simmons Cancer Center-Dallas|
|Dallas, Texas, United States, 75390|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|The Woman's Hospital of Texas|
|Houston, Texas, United States, 77054|
|MD Anderson Regional Care Center-Katy|
|Houston, Texas, United States, 77094|
|MD Anderson Regional Care Center-Bay Area|
|Nassau Bay, Texas, United States, 77058|
|MD Anderson Regional Care Center-Sugar Land|
|Sugar Land, Texas, United States, 77478|
|MD Anderson Regional Care Center-The Woodlands|
|The Woodlands, Texas, United States, 77384|
|Principal Investigator:||Robert Coleman||M.D. Anderson Cancer Center|