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

Primary Peritoneal Cavity Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036751
• Other study ID #: NCI-2012-02463
• Secondary ID: SWOG-S0211U10CA0
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2002
• Last updated: January 23, 2013
• Start date: April 2002

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer
• Stage III Ovarian Epithelial Cancer
• Stage IV Ovarian Epithelial Cancer

Intervention

Drug:
• imatinib mesylate
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Southwest Oncology Group (SWOG) Research Base	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete and partial confirmed response)		Up to 3 years	No
Secondary	Toxicity as assessed by NCI Common Toxicity Criteria version 2.0		Up to 3 years	Yes