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

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00897806
First received: May 9, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Ovarian Cancer
Peritoneal Cavity Cancer
Genetic: Microarray analysis
Other: Laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Genetic markers of paclitaxel chemosensitivity and/or chemoresistance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of RNA expression levels with clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate to weekly paclitaxel in chemotherapy naive patients [ Time Frame: Every 3 months post treatment ] [ Designated as safety issue: No ]
    Resonse measured by clinical assessments every 3 months post treatment.

  • Progression-free survival [ Time Frame: Every 3 months post treatment ] [ Designated as safety issue: No ]
    Influence of weekly paclitaxel followed by paclitaxel in combination with carboplatin on progression-free survival by clinical assessments every 3 months post treatment


Biospecimen Retention:   Samples With DNA

Tumor samples undergo transcriptional profiling using cDNA microarrays.


Enrollment: 7
Study Start Date: February 2002
Study Completion Date: February 2009
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Genetic Markers Genetic: Microarray analysis Other: Laboratory biomarker analysis

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 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 regimen.

Secondary

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897806

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David M. Gershenson, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00897806     History of Changes
Other Study ID Numbers: ID00-408, P50CA083639, P30CA016672, MDA-ID-00408, CDR0000355794
Study First Received: May 9, 2009
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014