Clinical trial NCT00840450: Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
Official title: Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian cancer
recurrent
Gleevec
Paclitaxel
Taxane
mullerian
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-02-10
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: the Best Overall Clinical Response
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression-free-tolerance
timeFrame: 12 weeks
measure: Progression-free-survival at 12 Months
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU cancer center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Franco M Muggia, MD
role: PRINCIPAL_INVESTIGATOR
References: