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| ID | Type | Description | Link |
|---|---|---|---|
| MAMC#206126 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.
Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Imatinib plus intravenous gemcitabine | Experimental | All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle. All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. . All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate by mouth | Drug | imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma. | Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease. | Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years. |
| To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria | Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria | Until disease progression or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment. | Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as "complete response", "partial response", "stable disease", and "progressive disease" after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study. the measurement reported is the number of patients who met the criteria for partial response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David McCune, MD, MPH | Madigan Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
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Three subjects were enrolled at Brooke Army Medical Center. Five subjects were enrolled at Madigan Army Medical Center.
Seven of eght subjects are deceased as of 4/4/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Imatinib Plus Gemcitabine | Open label, non-randomized, single treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Open label, non-randomized, single treatment group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma. | Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease. | of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment | Posted | Number | participants | Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years. |
|
Adverse event data were collected from initiation of treatment to 30 days off treatment.
Adverse events were scored based on NCI common toxicity criteria. All serious adverse events and all non-serious adverse events were reported.
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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 | Treatment | Open label, non-randomized, single treatment group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | NCI Common Toxicity | Non-systematic Assessment | Cellulitis of the leg developed, resolved with appropriate antibiotics and no sequelae |
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This study was terminated due to a combination of poor accrual and lack of evidence of benefit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| COL David E. McCune, MD, MC | Madigan Army Medical Center | 253-968-1155 | david.e.mccune.mil@mail.mil |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Gemcitabine Intravenous | Drug | Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle |
|
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| Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified |
| To Determine the Distribution of the Overall Survival | All subjects were followed after treatment was complete to assess overall survival. | Until death |
| To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial) | Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study. Repsonse rate was the sum of Complete Repsonse and Partial Response. | until disease progression or unacceptable toxicity |
| To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall. | The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done. | Until disease progression |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Open label, non-randomized, single treatment group. All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine. |
|
|
| Primary | To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria | Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria | Posted | Number | participants | Until disease progression or unacceptable toxicity |
|
|
|
| Secondary | Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment. | Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as "complete response", "partial response", "stable disease", and "progressive disease" after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study. the measurement reported is the number of patients who met the criteria for partial response. | All subjects who underwent treatment and participated in the study were analysed | Posted | Number | participants | Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified |
|
|
|
| Secondary | To Determine the Distribution of the Overall Survival | All subjects were followed after treatment was complete to assess overall survival. | Posted | Median | Full Range | months | Until death |
|
|
|
| Secondary | To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial) | Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study. Repsonse rate was the sum of Complete Repsonse and Partial Response. | All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals | Posted | Number | participants | until disease progression or unacceptable toxicity |
|
|
|
| Secondary | To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall. | The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done. | Posted | Until disease progression |
|
|
| 3 |
| 8 |
| 0 |
| 8 |
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| Pyelonephritis | Renal and urinary disorders | NCI Common Toxicity | Non-systematic Assessment | One subject pyelonephritis that was possibly study related and responded to treatment. |
|
| Allergic Reaction | Immune system disorders | NCI Common Toxicity | Non-systematic Assessment | One subject develoed tongue swelling after cycle #1. Treatment was discontinued and no other episodes were observed |
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| Neutropenia | Blood and lymphatic system disorders | NCI Common Toxicity | Systematic Assessment | Grade 4 neutropenia - treated with dose reduction |
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| 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 |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| Measurements |
|---|
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