Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	GOG-0170E NCT00041041

Objectives

1. Determine the cytostatic antitumor activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
2. Determine the frequency and severity of adverse effects of this drug in these patients.
3. Determine the distribution of overall and progression-free survival in patients treated with this drug.
4. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
5. Determine the effects of this drug on initial performance status, platinum sensitivity, and mucinous (or clear cell) histology in these patients.

Entry Criteria

Disease Characteristics:

• 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)

Prior/Concurrent Therapy:

Biologic therapy:

• At least 3 weeks since prior immunologic therapy directed at the malignant tumor
• No concurrent biologic therapy or immunotherapy for the malignant tumor

Chemotherapy:

• See Disease Characteristics
• 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

Endocrine therapy:

• 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

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy
• No prior radiotherapy to more than 25% of marrow-bearing areas
• No concurrent anticancer radiotherapy

Surgery:

• Recovered from recent prior surgery

Other:

• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2 (if patient has received one prior treatment regimen)
• GOG 0-1 (if patient has received two prior treatment regimens)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• 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

Expected Enrollment

A total of 22-60 patients will be accrued for this study within 4-15 months.

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.

Schilder RJ, Sill MW, Lee RB, et al.: Phase II evaluation of imatinib mesylate in the treatment of recurrent or persistent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol 26 (20): 3418-25, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Russell Schilder, MD, Protocol chair		Ph: 215-728-3545; 888-369-2427 Email: russell.schilder@fccc.edu

Registry Information
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
Trial Start Date		2002-06-03
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00041041
Date Submitted to PDQ		2002-05-22
Information Last Verified		2004-09-09
NCI Grant/Contract Number		U10-CA27469

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