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

This study has been terminated.
(Due to slow accrual)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00840450
First received: February 9, 2009
Last updated: November 12, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • Gleevec:Imatinib Mesylate
  • Paclitaxel: Taxol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840450

Locations
United States, New York
NYU cancer center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Novartis
Investigators
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2014