Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Gleevec/Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- the Best Overall Clinical Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Progression-free-tolerance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.
| Enrollment: | 14 |
| Study Start Date: | April 2007 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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).
Contacts and Locations| United States, New York | |
| NYU cancer center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Franco M Muggia, MD | New York University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00840450 History of Changes |
| Other Study ID Numbers: | 06-226, CSTI57BUS224 |
| Study First Received: | February 9, 2009 |
| Results First Received: | August 18, 2011 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
ovarian cancer recurrent Gleevec |
Paclitaxel Taxane mullerian |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Paclitaxel |
Imatinib Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013