Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00886691|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2009
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Biological: Bevacizumab Drug: Everolimus Other: Laboratory Biomarker Analysis Other: Placebo||Phase 2|
I. To estimate the progression-free survival hazard ratio of the combination of oral everolimus (RAD001) and bevacizumab compared to oral placebo and bevacizumab in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.
I. To determine the nature and degree of toxicity of oral everolimus (or placebo) plus bevacizumab.
II. To characterize and compare progression-free survival and overall survival in patients with measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) and patients with detectable (non-measurable) disease.
III. To estimate the proportion of patients with measurable disease who have objective tumor responses by treatment.
IV. To provide descriptive information about cancer antigen (CA)-125 responses by regimen and where possible by objective tumor responses.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and everolimus orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive bevacizumab as in Arm I and placebo PO QD on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Actual Study Start Date :||December 27, 2010|
|Actual Primary Completion Date :||March 23, 2015|
Experimental: Arm I (bevacizumab and everolimus)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and everolimus PO QD on days 1-28.
Other: Laboratory Biomarker Analysis
Experimental: Arm II (bevacizumab and placebo)
Patients receive bevacizumab as in Arm I and placebo PO QD on days 1-28.
Other: Laboratory Biomarker Analysis
- Progression-free Survival [ Time Frame: Duration of time from start of treatment to time of progression, assessed up to 5 years ]The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) [ Time Frame: All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment ]Number of participants with a grade of 3 or higher during the treatment period.
- Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease [ Time Frame: Continued until disease progression was assessed or up to 5 years in follow-up. ]Progression-free survival and overall survival broken down by measurable disease status
- The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment. [ Time Frame: Up to 5 years ]Complete and Partial Tumor Response by RECIST 1.0
- Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response [ Time Frame: Prior to each cycle of treatment. Then follow-up every three months for 2 years , then 6 months for 3 years for 5 years follow up. ]Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886691
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|Principal Investigator:||William Tew||NRG Oncology|