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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

Not Enrolling
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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



- 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


- 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.

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
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

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

7. Patients with significant pre-existing cardiac disease (NYHA class III-IV) will be

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Genetic markers of paclitaxel chemosensitivity and/or chemoresistance

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David M. Gershenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2002

Completion Date:

February 2009

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



UT MD Anderson Cancer CenterHouston, Texas  77030