Study Stopped
Due to slow accrual
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
2 other identifiers
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Apr 2007
Typical duration for phase_2 ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedResults Posted
Study results publicly available
September 26, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 19, 2012
November 1, 2012
3 years
February 9, 2009
August 18, 2011
November 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the Best Overall Clinical Response
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.
12 weeks
Secondary Outcomes (2)
Progression-free-tolerance
12 weeks
Progression-free-survival at 12 Months
up to 12 months
Study Arms (1)
Paclitaxel + Imatinib Mesylate (Gleevec)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Novartiscollaborator
Study Sites (1)
NYU cancer center
New York, New York, 10016, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Premature closure led to small numbers of subjects analyzed (12 out of 50 targeted accrual number).
Results Point of Contact
- Title
- Franco Muggia, MD
- Organization
- NYU Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Franco M Muggia, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
April 1, 2007
Primary Completion
April 1, 2010
Study Completion
October 1, 2012
Last Updated
November 19, 2012
Results First Posted
September 26, 2011
Record last verified: 2012-11