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Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent 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

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

Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Recurrent or persistent disease At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Tumors within a previously irradiated field considered nontarget lesions At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required Initial treatment may include high-dose, consolidation, or extended therapy Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) Performance status - GOG 0-2 (if patient has received one prior treatment regimen) Performance status - GOG 0-1 (if patient has received two prior treatment regimens) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No active infection requiring antibiotics No greater than grade 1 sensory and motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No signs or symptoms of bowel dysfunction At least 3 weeks since prior immunologic therapy directed at the malignant tumor No concurrent biologic therapy or immunotherapy for the malignant tumor Recovered from prior chemotherapy No prior noncytotoxic chemotherapy for persistent or recurrent disease One additional cytotoxic regimen for persistent or recurrent disease allowed No concurrent chemotherapy for the malignant tumor At least 1 week since prior hormonal therapy directed at the malignant tumor No concurrent therapeutic corticosteroids No concurrent anticancer hormonal therapy Concurrent hormone replacement therapy allowed Recovered from prior radiotherapy No prior radiotherapy to more than 25% of marrow-bearing areas No concurrent anticancer radiotherapy Recovered from recent prior surgery At least 3 weeks since other prior therapies directed at the malignant tumor No prior imatinib mesylate No prior anticancer therapy that would preclude study participation No concurrent therapeutic anticoagulation with warfarin No other concurrent investigational drugs No concurrent amifostine or other protective reagents

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (imatinib mesylate)

Arm Description

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival
Frequency and severity of adverse effects as assessed by CTC

Secondary Outcome Measures

Duration of overall survival
Duration of progression-free survival
Frequency of clinical response (partial and complete response)
Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology

Full Information

First Posted
July 8, 2002
Last Updated
February 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00041041
Brief Title
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Official Title
A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 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 persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the cytostatic, anti-tumor activity of Gleevec (Imatinib Mesylate) through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec. II. To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC. SECONDARY OBJECTIVES: I. To determine the distribution of the overall survival. II. To determine the distribution of progression-free survival. III. To estimate the clinical response rate (partial and complete response as defined under the RECIST criteria). IV. To assess the effects of prognostic variables: initial performance status, platinum sensitivity, and mucinous (or clear cell) histology). TERTIARY OBJECTIVES: I. To determine the levels of expression of c-KIT and its ligand, stem cell factor (SCF) in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy. II. To determine the levels of expression of platelet derived growth factor receptor (PDGFR) and its ligand PDGF in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy. III. To determine the levels of expression of AKT2 and its activated form, phospho-AKT2, in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment (imatinib mesylate)
Arm Type
Experimental
Arm Description
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days 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 PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
At 6 months
Title
Frequency and severity of adverse effects as assessed by CTC
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Duration of overall survival
Time Frame
Up to 7 years
Title
Duration of progression-free survival
Time Frame
Up to 7 years
Title
Frequency of clinical response (partial and complete response)
Time Frame
Up to 7 years
Title
Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Recurrent or persistent disease At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Tumors within a previously irradiated field considered nontarget lesions At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required Initial treatment may include high-dose, consolidation, or extended therapy Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) Performance status - GOG 0-2 (if patient has received one prior treatment regimen) Performance status - GOG 0-1 (if patient has received two prior treatment regimens) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No active infection requiring antibiotics No greater than grade 1 sensory and motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No signs or symptoms of bowel dysfunction At least 3 weeks since prior immunologic therapy directed at the malignant tumor No concurrent biologic therapy or immunotherapy for the malignant tumor Recovered from prior chemotherapy No prior noncytotoxic chemotherapy for persistent or recurrent disease One additional cytotoxic regimen for persistent or recurrent disease allowed No concurrent chemotherapy for the malignant tumor At least 1 week since prior hormonal therapy directed at the malignant tumor No concurrent therapeutic corticosteroids No concurrent anticancer hormonal therapy Concurrent hormone replacement therapy allowed Recovered from prior radiotherapy No prior radiotherapy to more than 25% of marrow-bearing areas No concurrent anticancer radiotherapy Recovered from recent prior surgery At least 3 weeks since other prior therapies directed at the malignant tumor No prior imatinib mesylate No prior anticancer therapy that would preclude study participation No concurrent therapeutic anticoagulation with warfarin No other concurrent investigational drugs No concurrent amifostine or other protective reagents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Schilder
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

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