Status:
TERMINATED
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
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Peritoneal Cavity Cancer
Eligibility:
All Genders
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...
Detailed Description
OBJECTIVES: Primary * Identify genetic markers of paclitaxel chemosensitivity and/or chemoresistance, using gene expression arrays, in patients with newly diagnosed stage III or IV ovarian epithelia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00897806
Start Date
February 1 2002
End Date
February 1 2009
Last Update
July 30 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030