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Ovarian CancerPhase 2NCT00510653

Gleevec Study for Patients With Ovarian Cancer

A Phase 2 study testing Imatinib Mesylate in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objectives: 1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL. 2. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Imatinib Mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
Mar 2002to Feb 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.
  • Patients with low-grade tumors may have failed unlimited prior therapies.
  • 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 staining.
  • 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.
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  • 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 > 100,000/Fl.
  • Patients must have adequate renal function as documented by a serum creatinine <2.0 mg/dL.
  • 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.
  • Patients must have an estimated life expectancy of 12 weeks or greater.
  • Zubrod performance status of 0, 1, or 2.
  • Patients must be older than age 18.
  • Patients must have signed an approved informed consent.

Who cannot join

  • Patients who have previously received Gleevec.
  • Patients with any active or uncontrolled infection, including known HIV infection.
  • Patients with psychiatric disorders that would interfere with consent or follow-up.
  • Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
  • 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.
  • Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
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  • Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible.
  • 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.
  • Patients with a deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.
  • Patients who are receiving warfarin.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

Primary Objectives:

  1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL.
  2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.
Read the detailed description

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.

Conditions
Ovarian Cancer
Being tested
Imatinib Mesylate
Keywords
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Recurrent Platinum-Resistant, Taxane-Resistant, Epithelial Ovarian Cancer, Imatinib Mesylate, Gleevec, STI571, Protein tyrosine kinase inhibitor
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib MesylateDrug

    Also called Imatinib, Gleevec, STI571, NSC-716051

    600 mg by mouth daily for 6 Weeks

Study groups in NCT00510653
Study groupRoleWhat they receive
Imatinib MesylateExperimental600 mg/day orally for 6 Weeks
Receives: Drug: Imatinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2007 (estimated)
  2. Study startMar 2002
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00510653
Sponsor's protocol ID
ID01-707
Status last verified
Jun 2013
First submitted
31 Jul 2007
Last updated
23 Aug 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib Mesylate in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 6 weeks with re-evaluation every 6 weeks or until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00510653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.

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