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

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: 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
Information provided by (Responsible Party):
New York University School of Medicine

February 9, 2009
February 10, 2009
August 18, 2011
September 26, 2011
November 19, 2012
April 2007
April 2010   (Final data collection date for primary outcome measure)
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.
the best overall clinical response (complete response and partial response) rates. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00840450 on Archive Site
  • 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.
  • Progression-free-tolerance [ Time Frame: 12 weeks ]
  • progression-free-survival [ Time Frame: till disease progression or death or end of study ]
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Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
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
Experimental: Paclitaxel + Imatinib Mesylate (Gleevec)
Intervention: Drug: Gleevec/Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
April 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CSTI57BUS224 ( Other Identifier: Novartis )
Not Provided
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New York University School of Medicine
New York University School of Medicine
Principal Investigator: Franco M Muggia, MD New York University School of Medicine
New York University School of Medicine
November 2012

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