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CompletedNCT00036751Updated Jan 24, 2013

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

A Phase 2 interventional study of imatinib mesylate and laboratory biomarker analysis in Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer and Stage III Ovarian Epithelial Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2013-01-24.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
03

In context

Carcinoma, Ovarian Epithelial

1,619 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 245 are open to participants now.

This study's enrollment of 40 is below the median of 48 across 1,196 interventional studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment (imatinib mesylate)

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

    Drug: imatinib mesylate · Other: laboratory biomarker analysis

Interventions

  • Drugimatinib mesylate

    Given orally

    Also known as: CGP 57148, Gleevec, Glivec

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Response rate (complete and partial confirmed response)

    Time frame: Up to 3 years

Secondary outcomes

  1. Toxicity as assessed by NCI Common Toxicity Criteria version 2.0

    Time frame: Up to 3 years

07

Study locations

1 site
  • Southwest Oncology Group (SWOG) Research Base
    San Antonio, Texas 78245, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2002 and a primary completion of Aug 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2002
First posted
Jan 27, 2003
Start
Apr 2002
Primary completionActual
Aug 2007
Last update
Jan 24, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00036751
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 2002
Primary completion
Aug 2007
Last update
Jan 24, 2013

Study contacts

David Alberts
principal investigator · SWOG Cancer Research Network
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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