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
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.
Peritoneal Cavity Cancer
Genetic: Microarray analysis
Other: Laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Genetic markers of paclitaxel chemosensitivity and/or chemoresistance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Correlation of RNA expression levels with clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Response rate to weekly paclitaxel in chemotherapy naive patients [ Time Frame: Every 3 months post treatment ] [ Designated as safety issue: No ]Resonse measured by clinical assessments every 3 months post treatment.
- Progression-free survival [ Time Frame: Every 3 months post treatment ] [ Designated as safety issue: No ]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
|Study Start Date:||February 2002|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
|Genetic Markers||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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|