Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
NCT ID: NCT00569673
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
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Detailed Description
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Primary
* To estimate the antitumor activity of docetaxel plus trabectedin in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer primarily through the frequency of objective tumor responses.
* To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients.
Secondary
* To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin.
OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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filgrastim
pegfilgrastim
docetaxel
trabectedin
Eligibility Criteria
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Inclusion Criteria
* GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS 0-1 after receiving 2 or more prior regimens)
* Platelet count ≥ 100,000/mm³
* ANC count ≥ 1,500/mm³
* Hemoglobin \> 9 g/dL
* Creatinine ≤ 1.5 times upper limit normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* CPK normal
* Bilirubin or direct bilirubin normal
* Alkaline phosphatase normal
* Neuropathy (sensory and motor) ≤ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics (except for uncomplicated UTI)
* No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer
* No known active liver disease or hepatitis
* Willing and able to have a central venous catheter
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from effects of recent surgery, radiotherapy, or chemotherapy
* At least 1 week since prior hormonal therapy directed at the malignant tumor
* Continuation of hormone replacement therapy allowed
* At least 3 weeks since other prior therapy, including biological and immunological therapy directed at the tumor
* Chimeric or human or humanized monoclonal antibodies must be discontinued for at least 6 weeks prior to study entry
* No investigational therapy within the past 30 days
* No prior therapy with docetaxel and/or trabectedin
* No radiation to more than 25% of marrow-bearing areas
* No prior cancer treatment that contraindicates protocol therapy
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Bradley J. Monk, MD
Role: STUDY_CHAIR
Chao Family Comprehensive Cancer Center
Kristine M. Zanotti, MD
Role:
MacDonald Physicians, Incorporated at University MacDonald Womens Hospital
Locations
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Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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Monk BJ, Sill MW, Hanjani P, Edwards R, Rotmensch J, De Geest K, Bonebrake AJ, Walker JL. Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2011 Mar;120(3):459-63. doi: 10.1016/j.ygyno.2010.11.012. Epub 2010 Dec 7.
Monk, M BJ, Sill M, Walker JL, et al.: Activity of docetaxel plus trabectedin in recurrent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). [Abstract] J Clin Oncol 28 (Suppl 15): A-5046, 2010.
Other Identifiers
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GOG-0186F
Identifier Type: -
Identifier Source: secondary_id
CDR0000577866
Identifier Type: -
Identifier Source: secondary_id
GOG-0186F
Identifier Type: -
Identifier Source: org_study_id
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