CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer
NCT ID: NCT01652079
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2012-04-30
2018-03-31
Brief Summary
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Camptothecin is a chemical extracted from plants that is the basis for the standard FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of camptothecin and a large molecule (nanoparticle)that appears to allow more of the camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the tumor may increase the probability that the tumor cells will be damaged.
CRLX101 has been well tolerated in the laboratory and in participants with different kinds of cancer.
Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer. Bevacizumab has been successfully combined with many chemotherapy partners.
It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique clinical activity in combination in the treatment of this disease due to the simultaneous inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this combination will work to treat your type of cancer.
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Detailed Description
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You will receive premedication including decadron, zantac and benadryl to help prevent an allergic reaction and nausea prior to your CRLX101 infusion.You will also receive IV fluid before and after the study drug administration to keep you hydrated. It will be important for you to drink water regularly in between study visits.You will be treated as an outpatient. At every clinic visit, you will undergo the following assessments: Medical history, physical examination, vital signs, performance status, routine blood tests, urine tests, assessment for any new side effects, CT evaluation (every 8 weeks).
You will have an end of study visit within 30 days of your last dose.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
CRLX101
CRLX101
q 14 days
Interventions
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CRLX101
q 14 days
Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* May have received up to 2 prior cytotoxic chemotherapy
* Life expectancy of greater than 3 months
Exclusion Criteria
* Prior camptothecin, prior VEFG inhibitors
* Gross hematuria
* Chemotherapy or radiotherapy within 4 weeks of study entry
* uncontrolled HTN
* Receiving other study agents
* History of allergic reaction to compounds of similar chemical or biologic composition to topotecan or irinotecan
* Known brain metastases
* History of a different malignancy within the previous 2 years
* Intercurrent illness
* HIV positive on combination antiretroviral therapy
18 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Richard Thomas Penson
Principal Investigator
Principal Investigators
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Richard Penson, MD, MRCP
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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11-485
Identifier Type: -
Identifier Source: org_study_id
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