View Clinical Trial (Medical Research Study)
A Phase II, 2-stage Trial of CRLX101-202 in Recurrent Ovarian, Tubal and Peritoneal Cancer
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Ovarian Cancer - Fallopian Tube Cancer - Primary Peritoneal Cancer |
| Purpose: |
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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.
In this research study, we are looking to see if CRLX101 works to treat your type of cancer.
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| Study Summary: |
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You will receive CRLX101 through an intravenous (IV) infusion over an hour once every 14
days. You will receive the study drug on days 1 and 15 of each cycle. Each cycle is 28 days.
You will continue to receive CRLX101 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,
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.
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| Criteria: |
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Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian, tubal or primary
peritoneal cancer
- Measurable disease
- May have received up to 3 prior cytotoxic chemotherapy
- Life expectancy of greater than 3 months
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior camptothecin
- Gross hematuria
- Chemotherapy or radiotherapy within 4 weeks of study entry
- 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
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| NCT ID: |
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NCT01652079 |
| Primary Contact: |
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Carolyn Krasner, MD
Phone: 6177244800
Email: cnkrasner@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02215
United States
Susana Campos, MD
Phone: 617-724-3858
Email: scampos@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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