search
Back to results

Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma No mixed Mullerian tumors No borderline ovarian tumors Stage III or IV disease at time of diagnosis by surgical staging Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially Measurable disease Performance status - Zubrod 0-1 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission At least 28 days since prior biologic therapy No concurrent anticancer biologic therapy No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) At least 28 days since prior chemotherapy No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen No concurrent chemotherapy Prior hormonal therapy allowed Recovered from prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery At least 14 days since prior major surgery Recovered from all prior surgery At least 28 days since prior investigational drugs No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed) No other concurrent anticancer agents No other concurrent investigational drugs

Sites / Locations

  • Southwest Oncology Group (SWOG) Research Base

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (imatinib mesylate)

Arm Description

Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate (complete and partial confirmed response)

Secondary Outcome Measures

Toxicity as assessed by NCI Common Toxicity Criteria version 2.0

Full Information

First Posted
May 13, 2002
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00036751
Brief Title
Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Official Title
A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth
Detailed Description
OBJECTIVES: I. Determine the response rates (confirmed, complete, and partial) in patients with platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal cancer treated with imatinib mesylate. II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (imatinib mesylate)
Arm Type
Experimental
Arm Description
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
CGP 57148, Gleevec, Glivec
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (complete and partial confirmed response)
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Toxicity as assessed by NCI Common Toxicity Criteria version 2.0
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma No mixed Mullerian tumors No borderline ovarian tumors Stage III or IV disease at time of diagnosis by surgical staging Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially Measurable disease Performance status - Zubrod 0-1 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission At least 28 days since prior biologic therapy No concurrent anticancer biologic therapy No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) At least 28 days since prior chemotherapy No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen No concurrent chemotherapy Prior hormonal therapy allowed Recovered from prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery At least 14 days since prior major surgery Recovered from all prior surgery At least 28 days since prior investigational drugs No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed) No other concurrent anticancer agents No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Alberts
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group (SWOG) Research Base
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

We'll reach out to this number within 24 hrs