Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5 other identifiers
interventional
51
1 country
20
Brief Summary
This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedResults Posted
Study results publicly available
December 13, 2013
CompletedJanuary 11, 2018
March 1, 2015
4.1 years
July 10, 2007
October 23, 2013
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels
Frequency and Severity of Observed Adverse Effects
Every cycle during treatment and up to 5 years after completion of treatment
Secondary Outcomes (2)
Progression-free Survival
from study entry until disease progression, death or date of last contact.
Overall Survival
from entry into the study to death or the date of last contact.
Study Arms (1)
Treatment (paclitaxel albumin-stabilized nanoparticle)
EXPERIMENTALPatients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of 1 of the following:
- Ovarian epithelial cancer
- Fallopian tube cancer
- Primary peritoneal carcinoma
- Recurrent or persistent disease
- Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment
- Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
- Platinum-resistant or refractory disease, defined by 1 of the following:
- Treatment-free interval of \< 6 months after completion of platinum-based therapy
- Persistent disease at completion of primary platinum-based therapy
- Progressive disease during platinum-based therapy
- Paclitaxel-resistant disease, defined as having had a treatment-free interval \< 6 months or shown disease progression during paclitaxel-based therapy
- Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (20)
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
North Shore-LIJ Health System CCOP
Manhasset, New York, 11030, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0565, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela M. Kuras, Associate Director of Data Management
- Organization
- NRG Oncology Statistics and Data Management Center - Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Coleman
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 11, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2011
Last Updated
January 11, 2018
Results First Posted
December 13, 2013
Record last verified: 2015-03