Study Stopped
Terminated due to slow accrual.
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
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
5 other identifiers
observational
7
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedJuly 30, 2012
July 1, 2012
4 years
May 9, 2009
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Genetic markers of paclitaxel chemosensitivity and/or chemoresistance
2 years
Correlation of RNA expression levels with clinical response
2 years
Secondary Outcomes (2)
Response rate to weekly paclitaxel in chemotherapy naive patients
Every 3 months post treatment
Progression-free survival
Every 3 months post treatment
Study Arms (1)
Genetic Markers
Interventions
Eligibility Criteria
Patients with newly diagnosed Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer.
You may qualify if:
- Patients with newly diagnosed histologically confirmed advanced stage (III \& IV) epithelial ovarian cancer, fallopian tube or peritoneal cancer. --OR-- Patients with a suspected malignancy who are unsuitable candidates for surgery (i.e., those with medical co-morbidities, massive effusions, or tumor burden such that an optimal resection is unlikely) who undergo a core biopsy that is positive for malignancy.
- Patients who have undergone tumor reduction must have either stage III suboptimal (\> 2 cm residual) disease or stage IV disease.
- Patients may have had no prior chemotherapeutic regimen.
- Zubrod performance status of 0, 1, or 2.
- Patients must have recovered from effects of recent surgery. They should be free of significant infection.
- 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.
- 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.
- Patients who have signed an approved informed consent.
You may not qualify if:
- Patients with borderline or grade 1 (low grade) tumors.
- Patients who have received any prior cytotoxic chemotherapy or radiotherapy.
- Patients with septicemia, severe infection, acute hepatitis, or gastrointestinal bleeding at the time of protocol entry.
- 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.
- Patients whose circumstances do not permit completion of the study or the required follow-up.
- 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.
- Patients with significant pre-existing cardiac disease (NYHA class III-IV) will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Tumor samples undergo transcriptional profiling using cDNA microarrays.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David M. Gershenson, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
February 1, 2002
Primary Completion
February 1, 2006
Study Completion
February 1, 2009
Last Updated
July 30, 2012
Record last verified: 2012-07