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

NCT ID: NCT00041041

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (imatinib mesylate)

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.

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

imatinib mesylate

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CGP 57148; Gleevec; Glivec

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Schilder

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

GOG-0170E

Identifier Type: -

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069438

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02473

Identifier Type: -

Identifier Source: org_study_id