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
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|ClinicalTrials.gov Identifier: NCT00569673|
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : June 26, 2014
Last Update Posted : July 18, 2018
RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells.
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: filgrastim Biological: pegfilgrastim Drug: docetaxel Drug: trabectedin||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # 101018) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||January 2012|
- Objective Tumor Response [ Time Frame: every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years) ]
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6
- Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Prior to each cycle and 30 days after the last cycle (average of 5 months) ]
- Duration of Progression-free Survival and Overall Survival [ Time Frame: up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569673
|Study Chair:||Bradley J. Monk, MD||Chao Family Comprehensive Cancer Center|
|OverallOfficial:||Kristine M. Zanotti, MD||MacDonald Physicians, Incorporated at University MacDonald Womens Hospital|