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Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

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ClinicalTrials.gov Identifier: NCT00840450
Recruitment Status : Terminated (Due to slow accrual)
First Posted : February 10, 2009
Results First Posted : September 26, 2011
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Results First Submitted Date  ICMJE August 18, 2011
Results First Posted Date  ICMJE September 26, 2011
Last Update Posted Date November 19, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2011)
the Best Overall Clinical Response [ Time Frame: 12 weeks ]
This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
the best overall clinical response (complete response and partial response) rates. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
  • Progression-free-tolerance [ Time Frame: 12 weeks ]
    This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.
  • Progression-free-survival at 12 Months [ Time Frame: up to 12 months ]
    This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • progression-free-tolerance [ Time Frame: 12 weeks ]
  • progression-free-survival [ Time Frame: till disease progression or death or end of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
Official Title  ICMJE Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
Brief Summary This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Gleevec/Paclitaxel

One treatment cycle:

Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days.

Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days.

After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression.

Other Names:
  • Gleevec:Imatinib Mesylate
  • Paclitaxel: Taxol
Study Arms  ICMJE Experimental: Paclitaxel + Imatinib Mesylate (Gleevec)
Intervention: Drug: Gleevec/Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 26, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
50
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients at least 18 years of age.
  • Histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen.

    *Eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease.

  • Measurable disease.
  • Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .
  • Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.0 x 10E9/L, platelets > 100 x 10E9/L.
  • Written, voluntary informed consent.

Exclusion Criteria:

  • Patient has received any other anticancer treatment within 21 days of first day of study drug dosing and shown recovery of any recent drug-induced neutropenia and thrombocytopenia.
  • Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
  • Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
  • Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Patients on coumadin-derived anticoagulants.
  • Patient with brain metastasis.
  • Chronic liver disease, Hep B or C.
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Patient received chemotherapy within 3 weeks -unless the disease is rapidly progressing.
  • Patient previously received radiotherapy to at least 25 % of the bone marrow.
  • Patient had a major surgery within 2 weeks prior to study entry.
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  • Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or others on the list on page 33-37 of the protocol).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840450
Other Study ID Numbers  ICMJE 06-226
CSTI57BUS224 ( Other Identifier: Novartis )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Franco M Muggia, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP