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
NCT ID: NCT00897806
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
7 participants
OBSERVATIONAL
2002-02-28
2009-02-28
Brief Summary
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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.
Detailed Description
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Primary
* 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.
Secondary
* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Genetic Markers
Microarray analysis
Laboratory biomarker analysis
Interventions
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Microarray analysis
Laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
2. Patients who have undergone tumor reduction must have either stage III suboptimal (\> 2 cm residual) disease or stage IV disease.
3. Patients may have had no prior chemotherapeutic regimen.
4. Zubrod performance status of 0, 1, or 2.
5. Patients must have recovered from effects of recent surgery. They should be free of significant infection.
6. Patients must have adequate: Bone marrow function: WBC \>/= than 3,000/microlitre, platelets \> 100,000/microlitre, absolute neutrophil (ANC) count \>/= than 1.5/microlitre. Renal function: Creatinine \</= 1.5 mg%. Hepatic function: Bilirubin \</= 1.5 mg/dl, SGOT and alkaline phosphatase \</= 3 X institutional normal.
7. Patients must have adequate: Neurologic function: Pre-existing peripheral neurologic toxicity is allowed but limited to parasthesia and decreased vibratory sense without motor weakness. Intermittent constipation managed with laxatives is allowed, without evidence of bowel obstruction. Psychiatric function: Functions independently without evidence of delirium, confusion, suicidal ideation, or untreated depression.
8. Patients who have signed an approved informed consent.
Exclusion Criteria
2. Patients who have received any prior cytotoxic chemotherapy or radiotherapy.
3. Patients with septicemia, severe infection, acute hepatitis, or gastrointestinal bleeding at the time of protocol entry.
4. Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block, etc.) are eligible if their disease has been stable for the past six months.
5. Patients whose circumstances do not permit completion of the study or the required follow-up.
6. Patients with a history of another malignancy within 5 years. Patients who have had a prior malignancy but remain continuously free of recurrent or persistent disease for more than 5 years may be entered in the study after consultation with the study chair.
7. Patients with significant pre-existing cardiac disease (NYHA class III-IV) will be excluded.
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David M. Gershenson, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-00408
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000355794
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID00-408
Identifier Type: -
Identifier Source: org_study_id