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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


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Feasibility

Outcome Description:

Number of patients meeting 3 week feasibility window which was set as the benchmark.

Outcome Time Frame:

1 year, 2 months

Safety Issue:

No

Principal Investigator

Robert M. Wenham, M.D., M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-15042

NCT ID:

NCT00720096

Start Date:

July 2008

Completion Date:

October 2009

Related Keywords:

  • Ovarian Cancer
  • Persistent Ovarian Cancer
  • Genomic directed salvage chemotherapy
  • Genomic Microarray
  • Ovarian Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612