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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):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Gleevec/Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
Study Start Date : April 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: Paclitaxel + Imatinib Mesylate (Gleevec) 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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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:

  • 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).

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): NCT00840450

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United States, New York
NYU cancer center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Franco M Muggia, MD NYU Langone Health
Additional Information:
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Responsible Party: NYU Langone Health Identifier: NCT00840450    
Other Study ID Numbers: 06-226
CSTI57BUS224 ( Other Identifier: Novartis )
First Posted: February 10, 2009    Key Record Dates
Results First Posted: September 26, 2011
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by NYU Langone Health:
ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Imatinib Mesylate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors