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CRLX101 for Recurrent Ovarian/Tubal/Peritoneal Cancer

This study is currently recruiting participants.
Verified July 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Carolyn N. Krasner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01652079
First received: July 25, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
 Drug: CRLX101
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, 2-stage Trial of CRLX101-202 in Recurrent Ovarian, Tubal and Peritoneal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Progression free survival at 6 months (PFS6) using RECIST 1.1


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response Rate (CR+PR) using RECIST 1.1

  • Assessment of Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Assessment of toxicity

  • Analysis of biopsies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analysis of ovarian tumor biopsies and ascites of the presence or absence of CRLX101 or the active drug, camptothecin


Estimated Enrollment: 29
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
CRLX101
 Drug: CRLX101
q 14 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652079

Contacts
Contact: Carolyn Krasner, MD 6177244800 cnkrasner@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susana Campos, MD     617-724-3858     scampos@partners.org    
Principal Investigator: Susana Campos, MD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susana Campos, MD     617-724-3858     scampos@partners.org    
Principal Investigator: Susana Campos, MD            
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Pangiotis Konstantinopolous, MD     617-667-9259     pkonstan@bidmc.harvard.edu    
Principal Investigator: Pangiotis Konstantinopolous, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Carolyn Krasner, MD     617-726-1941     cnkrasner@partners.org    
Contact: Christina Illiano, RN     617 643-5050     cilliano@partners.org    
Principal Investigator: Carolyn Krasner, MD            
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Carolyn N. Krasner, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01652079     History of Changes
Other Study ID Numbers: 11-485
Study First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Epithelial
Primary

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on June 18, 2013