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A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant, Taxane-Resistant Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant, Taxane-Resistant Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Imatinib Mesylate is a new medication that blocks several proteins important in the
development of cancer. Before going on study, potential participants will have their tumor
tested for c-KIT, PDGFR, and ABL for positivity. Those participants who have at least one
positive biomarker will be eligible for treatment.

Before treatment starts, participants will have a complete checkup, blood tests, chest
x-ray, and heart function test. Women able to have children must have a negative blood
pregnancy test. A blood sample (3 teaspoons) will be taken once a week during treatment and
at the end of treatment. A complete exam will also be done at the end of treatment. Tumors
will be measured by computed tomography (CT) scan every 6 weeks while one study and at the
end of treatment.

Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily
basis. Participants will be treated for 6 weeks, which is one cycle of therapy. After 6
weeks, participants will be evaluated for side effects and tumor response. The dose may be
decreased for the next cycle if participants side effects. Participants will be removed
from the study if the tumor gets worse. Participants may remain on the study as long as the
tumor has not gotten worse and there are no intolerable side effects.

This is an investigational study. Imatinib Mesylate has been approved for chronic
myelogenous leukemia patients. However this is an investigational study of Imatinib
Mesylate in patients with ovarian, tubal, or peritoneal cancer. Participants may responsible
for the cost of all or part of this drug. At least 24 and as many as 74 patients will take
part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Histologically confirmed metastatic epithelial ovarian, primary peritoneal cancer, or
fallopian tube cancer previously treated with a platinum/taxane-containing regimen.
Patients may have either low-grade or high-grade recurrent epithelial tumors.

2. Patients with high-grade tumors must be platinum/taxane resistant, as defined by:
progression of disease while on a first-line platinum/taxane regimen or tumor
progression within 6 months of completion of a platinum/taxane regimen.

3. Patients with high-grade tumors may have failed no more than 4 prior chemotherapy
regimens. All taxane/platinum therapies will be counted as one regimen.

4. Patients with low-grade tumors may have failed unlimited prior therapies.

5. Patients' tumor tissue must express one or more of the following biomarkers: c-KIT,
PDGFR or ABL. Positivity will be defined as 2+ or 3+ on immunohistochemical

6. All patients must have measurable disease. Measurable disease is defined as lesions
which can be measured by physical examination or by means of imaging techniques.
Ascites and pleural effusions are not to be considered measurable disease. An
elevated serum CA 125 level without associated measurable tumor is not to be
considered measurable disease.

7. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils +
bands) of > 1,500/Fl, a hemoglobin level of = 9.0 gm/dL and a platelet count of >

8. Patients must have adequate renal function as documented by a serum creatinine <2.0

9. Patients must have adequate hepatic function as documented by a serum bilirubin <1.5
mg/dL, regardless of whether patients have liver involvement secondary to tumor.
Aspartate transaminase (SGOT) must be < 3* institutional upper limit of normal unless
the liver is involved with tumor, in which case the aspartate transaminase must be <
5* institutional upper limit of normal.

10. Patients must have an estimated life expectancy of 12 weeks or greater.

11. Zubrod performance status of 0, 1, or 2.

12. Patients must be older than age 18.

13. Patients must have signed an approved informed consent.

Exclusion Criteria:

1. Patients who have previously received Gleevec.

2. Patients with any active or uncontrolled infection, including known HIV infection.

3. Patients with psychiatric disorders that would interfere with consent or follow-up.

4. Patients with a history of myocardial infarction within the previous six months or
congestive heart failure requiring therapy.

5. Patients with a history of prior malignancy except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease-free for at least five years.

6. Pregnant or lactating women. Men and women of reproductive potential may not
participate unless they have agreed to use an effective contraceptive method.

7. Presence of clinically apparent central nervous system metastases or carcinomatous

8. Patients with a history of seizures are ineligible. Patients receiving phenytoin,
phenobarbital, or other antiepileptic prophylaxis are ineligible.

9. Patients with any other severe concurrent disease which in the judgment of the
investigator, would make the patient inappropriate for entry into this study,
including significant hepatic, renal, or gastrointestinal diseases.

10. Patients with a deep venous or arterial thrombosis (including pulmonary embolism)
within 6 weeks of study entry.

11. Patients who are receiving warfarin.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.

Outcome Time Frame:

6 weeks with re-evaluation every 6 weeks or until disease progression

Safety Issue:


Principal Investigator

David Gershenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2002

Completion Date:

February 2012

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Recurrent Platinum-Resistant
  • Taxane-Resistant
  • Epithelial Ovarian Cancer
  • Imatinib Mesylate
  • Gleevec
  • STI571
  • Protein tyrosine kinase inhibitor
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



UT MD Anderson Cancer CenterHouston, Texas  77030