Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CSTI57BUS224 | Other Identifier | Novartis |
Not provided
Not provided
Not provided
Due to slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel + Imatinib Mesylate (Gleevec) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gleevec/Paclitaxel | Drug | One treatment cycle: Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days. Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days. After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression. |
| Measure | Description | Time Frame |
|---|---|---|
| the Best Overall Clinical Response | This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free-tolerance | This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment. | 12 weeks |
Not provided
Inclusion Criteria:
Patients at least 18 years of age.
Histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen.
*Eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease.
Measurable disease.
Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .
Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.0 x 10E9/L, platelets > 100 x 10E9/L.
Written, voluntary informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franco M Muggia, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU cancer center | New York | New York | 10016 | United States |
Not provided
| Label | URL |
|---|---|
| publication for this trial | View source |
Not provided
Not provided
14 patients were enrolled into this study from April 2007 to August 2009 from New York University medical center and affiliated hospitals. Only 12 were evaluable since 2 patients never received treatment because of rapid symptomatic deterioration.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel and Imatinib Mesylate (Gleevec) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel and Imatinib Mesylate (Gleevec) |
| 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 Best Overall Clinical Response | This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment. | The analysis is based on the intent-to-treat population. | Posted | Number | percentage of participants | 12 weeks |
|
|
treatment period (up to 5 months) plus 30 days after treatment or until the the adverse events have resolved or returned to pretreatment values or deemed irreversible.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel and Imatinib Mesylate (Gleevec) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | General disorders | CTCAE (Unspecified) | Systematic Assessment |
Premature closure led to small numbers of subjects analyzed (12 out of 50 targeted accrual number).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franco Muggia, MD | NYU Cancer Institute | 212-263-6485 | franco.muggia@nyumc.org |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Progression-free-survival at 12 Months | This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment. | up to 12 months |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Platinum Sensitivity | Number | Participants |
|
|
|
| Secondary | Progression-free-tolerance | This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment. | Based on intent-to-treat population. | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| Secondary | Progression-free-survival at 12 Months | This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment. | Based on intent-to-treat population. | Posted | Number | percentage of participants | up to 12 months |
|
|
|
| 3 |
| 12 |
| 11 |
| 12 |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Mucostitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Palpitation | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Shortness of breath | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| skin toxicity | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |