Brief Title
CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer
Official Title
A Phase II, 2-stage Trial of CRLX101 in Combination With Bevacizumab in Recurrent Platinum-Resistant Ovarian, Tubal and Peritoneal Cancer
Brief Summary
This research study is a Phase II clinical trial. In addition to studying safety, Phase II
clinical trials test if the investigational drug is effective and whether the drug works in
treating a specific cancer. "Investigational" means that the drug is still being studied and
that research doctors are trying to find out more about it-such as the safest dose to use,
the side effects it may cause, and if the drug is effective for treating different types of
cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet
approved CRLX101 for your type of cancer.
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.
Detailed Description
You will receive CRLX101 and bevacizumab through an intravenous (IV) infusion once every 14
days. Each cycle is 28 days. You will continue to receive both drugs until you and/or the
research doctor decides it may not be in your best interest to continue.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression Free Survival
Secondary Outcome
Response Rate
Condition
Ovarian Cancer
Intervention
CRLX101
Study Arms / Comparison Groups
Treatment Arm
Description: CRLX101
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
63
Start Date
April 2012
Completion Date
March 2018
Primary Completion Date
March 2018
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian, tubal or primary
peritoneal cancer
- Measurable disease
- May have received up to 2 prior cytotoxic chemotherapy
- Life expectancy of greater than 3 months
Exclusion Criteria:
- Pregnant or breastfeeding
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Richard Penson, MD, MRCP, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01652079
Organization ID
11-485
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
Richard Penson, MD, MRCP, Principal Investigator, Massachusetts General Hospital
Verification Date
June 2018