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Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00720096
Recruitment Status : Terminated (Funds for this project have been spent, and it is thereby terminated.)
First Posted : July 22, 2008
Results First Posted : February 16, 2011
Last Update Posted : January 2, 2018
United States Department of Defense
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:

This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer.

Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions.

Recent data suggest that microarray technology can predict a patient's response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Liposomal Doxorubicin Drug: Topotecan Not Applicable

Detailed Description:

Patients who take part in the study will have an initial visit and undergo a CT guided core biopsy. Using tissue from a CT guided core biopsy, microarray analysis will be performed to help predict which of the two drugs appears to be better suited to individual genomic factors. The results will result in being assigned to treatment with either liposomal doxorubicin or topotecan.

Patients who receive liposomal doxorubicin - IV chemotherapeutic treatment will occur 3 times, 28 days apart, weeks 1,5,and 9. At each of these visits patients will be evaluated and have blood work to check their liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor.

Patients who receive topotecan - IV chemotherapeutic treatment will occur 4 times, 21 days apart, weeks 1,4,7, and 10. At each of these visits patients will be evaluated and have blood work to check levels of liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Prospective Trial Of Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan In Recurrent Or Persistent Ovarian Cancer Within 12 Months Of Platinum-Based Chemotherapy
Study Start Date : July 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Drug: Liposomal Doxorubicin
Liposomal Doxorubicin 40 mg/m2 q 28 days
Other Name: Doxil

Experimental: Topotecan
Topotecan - Chemotherapy single agent systemic.
Drug: Topotecan
  1. Topotecan (daily x 5 days of a 21 day cycle)
  2. Per amendment #15: Topotecan (days 1, 8, 15 of a 28 day cycle)
Other Name: Hycamtin

Primary Outcome Measures :
  1. Assess Feasibility [ Time Frame: 1 year, 2 months ]
    Number of patients meeting 3 week feasibility window which was set as the benchmark.

  2. Interpret Genomic Array [ Time Frame: 1 year, 2 months ]
    Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 1 year, 2 months ]
    Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have history of histologically or cytologically confirmed epithelial ovarian cancer with recurrence.
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral computed tomography CT) scan.
  • May have had only 2 prior chemotherapy regimens, with at least one regimen containing platinum, and disease recurrence or progression occurring between 0 to 12 months (1 to 365 days)from the platinum-containing regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy and immunotherapy will not be considered a prior chemotherapy regimen. Hormonal therapies given to treat the patient's cancer should be stopped at least 30 days prior to dosing on this trial. Typical low-dose hormone replacement therapy to treat postmenopausal symptoms may be continued at the treating physician's discretion.
  • Life expectancy >6 months.
  • ECOG performance status 2 or less (Karnofsky 60%).
  • Must have normal organ and marrow function as defined below:

    • leukocytes 3,000/microL
    • absolute neutrophil count 1,500/ microL
    • platelets 100,000/microL
    • total bilirubin ≤1.5 X institutional upper limit of normal(ULN) aspartate aminotransferase [AST(SGOT)]/alanine aminotransferase [ALT(SGPT)] ≤2.5 X ULN creatinine within normal institutional limits OR creatinine clearance 60mL/min/1.73m2 for patients with creatinine levels above institutional normal
  • Ability to understand and willingness to sign a written informed consent document
  • Measurable disease on CT must be considered amenable to biopsy by Core methods (core biopsy may be radiographically or non-radiographically performed). Potential ability to obtain core material must be reviewed by Principal Investigator (PI) and/or his designates prior to enrollment.
  • Must consent to biopsy as part of enrolling into trial.
  • Patients with reproductive potential must use an adequate contraceptive method (e.g. abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
  • Must have a Multiple Gated Acquisition (MUGA) scan or 2-d echocardiogram indicating an ejection fraction of > 50% or institutional standards within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not version 13, 01/10/08 MCC 15042 16 recovered from adverse events due to agents administered more than 4 weeks earlier.
  • May not be receiving any other investigational agents concurrently.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal doxorubicin or topotecan.
  • Myocardial infarction within 6 months. History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant.
  • Women who are breastfeeding should discontinue breastfeeding.
  • Human Immunodeficiency Virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions and increased toxicity.
  • Patients may have had no other malignancies in the prior 5 years other than non-metastatic, locally-controlled, non-melanomatous cutaneous cancers.
  • Patients who have received radiation to more than 25% of marrow-bearing areas.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00720096

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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
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Principal Investigator: Robert M. Wenham, M.D., M.S. H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT00720096    
Other Study ID Numbers: MCC-15042
NFGC 12-12990-01-29 ( Other Identifier: NFGC )
First Posted: July 22, 2008    Key Record Dates
Results First Posted: February 16, 2011
Last Update Posted: January 2, 2018
Last Verified: December 2017
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Persistent Ovarian Cancer
Genomic directed salvage chemotherapy
Genomic Microarray
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors