Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT04753216
- Phase
- PHASE2
- Status
- Completed
Conditions
- Platinum-Resistant Fallopian Tube Carcinoma
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Refractory Fallopian Tube Carcinoma
- Refractory Ovarian Carcinoma
- Refractory Primary Peritoneal Carcinoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — BIOLOGICALGiven IV
- Irinotecan Sucrosofate — DRUGGiven IV
Study Details
This phase II trial investigates the effect of irinotecan liposome and bevacizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that shows less response to platinum therapy (platinum resistant), has come back (recurrent), or does not respond to treatment (refractory). Irinotecan liposome may help block the formation of growths that may become cancer. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving irinotecan liposome and bevacizumab may kill more cancer cells.
Key Dates
- Start date
- Mar 16, 2021
- Status verified
- Dec 2022
- Primary completion
- Aug 31, 2021
- Completion
- Oct 25, 2021
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (bevacizumab, irinotecan sucrosofate)Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: Up to 5 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | - |
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