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

Stopped early

Conditions studied: Ovarian Cancer, Peritoneal Cavity Cancer

In brief

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.

Key facts

Study ID: NCT00897806
Run by: M.D. Anderson Cancer Center
People needed: 7
Starts: 2002-02-01
Expected to finish: 2009-02-01
Last updated by the study team: 2012-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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