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

Ovarian Cancer Clinical Trial

Official title:

Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00840450
• Other study ID #: 06-226
• Secondary ID: CSTI57BUS224
• Status: Terminated
• Phase: Phase 2
• First received: February 9, 2009
• Last updated: November 12, 2012
• Start date: April 2007
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	NYU cancer center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-free-tolerance	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.	12 weeks	Yes
Secondary	Progression-free-survival at 12 Months	This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.	up to 12 months	No

External Links

•   publication for this trial