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A Phase II, 2-stage Trial of CRLX101-202 in Recurrent Ovarian, Tubal and Peritoneal Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

A Phase II, 2-stage Trial of CRLX101-202 in Recurrent Ovarian, Tubal and Peritoneal Cancer

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Progression free survival at 6 months (PFS6) using RECIST 1.1

Outcome Time Frame:

6 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Epithelial
  • Primary
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617