Ovarian Cancer
Conditions
Keywords
ovarian cancer, recurrent, Gleevec, Paclitaxel, Taxane, mullerian
Brief summary
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.
Interventions
DRUGGleevec/Paclitaxel
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.
Sponsors
Novartis
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
* Patient has received any other anticancer treatment within 21 days of first day of study drug dosing and shown recovery of any recent drug-induced neutropenia and thrombocytopenia. * Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ. * Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study). * Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). * Patients on coumadin-derived anticoagulants. * Patient with brain metastasis. * Chronic liver disease, Hep B or C. * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. * Patient received chemotherapy within 3 weeks -unless the disease is rapidly progressing. * Patient previously received radiotherapy to at least 25 % of the bone marrow. * Patient had a major surgery within 2 weeks prior to study entry. * Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. * Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or others on the list on page 33-37 of the protocol).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Best Overall Clinical Response | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free-tolerance | 12 weeks | 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. |
| Progression-free-survival at 12 Months | up to 12 months | This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel and Imatinib Mesylate (Gleevec) | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Paclitaxel and Imatinib Mesylate (Gleevec) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 8 |
| Platinum Sensitivity Resistant | 10 Participants |
| Platinum Sensitivity Sensitive | 2 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 12 |
| serious Total, serious adverse events | 3 / 12 |
Outcome results
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.
Time frame: 12 weeks
Population: The analysis is based on the intent-to-treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel and Imatinib Mesylate (Gleevec) | the Best Overall Clinical Response | 33 percentage of participants |
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.
Time frame: up to 12 months
Population: Based on intent-to-treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel and Imatinib Mesylate (Gleevec) | Progression-free-survival at 12 Months | 17 percentage of 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.
Time frame: 12 weeks
Population: Based on intent-to-treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel and Imatinib Mesylate (Gleevec) | Progression-free-tolerance | 75 percentage of participants |