Ovarian Cancer Clinical Trial
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
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | February 2009 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. 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. 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: 1. Patients with borderline or grade 1 (low grade) tumors. 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genetic markers of paclitaxel chemosensitivity and/or chemoresistance | 2 years | No | |
Primary | Correlation of RNA expression levels with clinical response | 2 years | No | |
Secondary | Response rate to weekly paclitaxel in chemotherapy naive patients | Resonse measured by clinical assessments every 3 months post treatment. | Every 3 months post treatment | No |
Secondary | Progression-free survival | Influence of weekly paclitaxel followed by paclitaxel in combination with carboplatin on progression-free survival by clinical assessments every 3 months post treatment | Every 3 months post treatment | No |
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