Identifying Genetic Markers That Predict Response to Paclitaxel in Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00897806|
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : May 12, 2009
Last Update Posted : July 30, 2012
RATIONALE: DNA analysis of tumor tissue from patients with cancer may help doctors predict how patients respond to treatment and plan the best treatment.
PURPOSE: This laboratory study is identifying genetic markers that predict response to paclitaxel in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
|Condition or disease||Intervention/treatment|
|Ovarian Cancer Peritoneal Cavity Cancer||Genetic: Microarray analysis Other: Laboratory biomarker analysis|
- Identify genetic markers of paclitaxel chemosensitivity and/or chemoresistance, using gene expression arrays, in patients with newly diagnosed stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with single-agent weekly paclitaxel followed by paclitaxel in combination with carboplatin.
- Correlate RNA expression levels with clinical response in patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Compare transcriptional profiles of primary tumors vs tissue obtained at second-look surgery in patients treated with this regimen.
- Identify differential expression between pre- and post-treatment tissue in patients treated with this regimen.
OUTLINE: This is a pilot study.
Pre- and post-chemotherapy tumor samples undergo transcriptional profiling using cDNA microarrays to identify gene overexpression. The gene expression profiles of paclitaxel-sensitive tumors are compared with those that are paclitaxel resistant to identify gene markers that are associated with response to paclitaxel.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||Feasibility of Measuring Gene Expression Patterns Using Tissue Acquisition of Primary Stage 3 & 4 Epithelial Ovarian Cx or Primary Peritoneal Cx & Gene Expression Array Technology for Predicting Paclitaxel Chemotherapy|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2009|
|Genetic Markers||Genetic: Microarray analysis Other: Laboratory biomarker analysis|
- Genetic markers of paclitaxel chemosensitivity and/or chemoresistance [ Time Frame: 2 years ]
- Correlation of RNA expression levels with clinical response [ Time Frame: 2 years ]
- Response rate to weekly paclitaxel in chemotherapy naive patients [ Time Frame: Every 3 months post treatment ]Resonse measured by clinical assessments every 3 months post treatment.
- Progression-free survival [ Time Frame: Every 3 months post treatment ]Influence of weekly paclitaxel followed by paclitaxel in combination with carboplatin on progression-free survival by clinical assessments every 3 months post treatment
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897806
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David M. Gershenson, MD||M.D. Anderson Cancer Center|