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Primary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib Mesylate | Experimental | 600 mg/day orally for 6 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate | Drug | 600 mg by mouth daily for 6 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks with re-evaluation every 6 weeks or until disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gershenson, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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Of the 73 enrolled, 27 were excluded as not eligible and one inevaluable for the study. Another four (4) participants were found to be not eligible following screening.
Recruitment Period: March 7, 2002 to September 30, 2009. All registration was done at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imatinib Mesylate | 600 mg/day orally for 6 Weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imatinib Mesylate | 600 mg/day orally for 6 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy. | Posted | Number | participants | 6 weeks with re-evaluation every 6 weeks or until disease progression |
|
7 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imatinib Mesylate | 600 mg/day orally for 6 Weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Gershenson, MD / Professor | The University of Texas (UT) MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
600 mg/day orally for 6 Weeks |
|
|
| 4 |
| 13 |
| 12 |
| 13 |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Nausea-vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Edema | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy (sensory) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weight Gain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |