Trial Outcomes & Findings for Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin (NCT NCT00840450)

Last Updated: 2012-11-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-11-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Paclitaxel and Imatinib Mesylate (Gleevec)
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel and Imatinib Mesylate (Gleevec)
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	2

Baseline Characteristics

Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Platinum Sensitivity Resistant	10 Participants n=5 Participants
Platinum Sensitivity Sensitive	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis is based on the intent-to-treat population.

Outcome measures

Outcome measures
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 Participants
the Best Overall Clinical Response	33 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Based on intent-to-treat population.

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.

Outcome measures

Outcome measures
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 Participants
Progression-free-tolerance	75 percentage of participants

SECONDARY outcome

Timeframe: up to 12 months

Population: Based on intent-to-treat population.

This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.

Outcome measures

Outcome measures
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 Participants
Progression-free-survival at 12 Months	17 percentage of participants

Adverse Events

Paclitaxel and Imatinib Mesylate (Gleevec)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 participants at risk
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • 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.
Blood and lymphatic system disorders Neutropenia	16.7% 2/12 • Number of events 2 • 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.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Paclitaxel and Imatinib Mesylate (Gleevec) n=12 participants at risk
General disorders Alopecia	41.7% 5/12 • 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.
Blood and lymphatic system disorders Anemia	91.7% 11/12 • 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.
Gastrointestinal disorders Diarrhea	41.7% 5/12 • 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.
General disorders Edema	16.7% 2/12 • 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.
General disorders Fatigue	75.0% 9/12 • 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.
General disorders Headache	8.3% 1/12 • 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.
Gastrointestinal disorders Mucostitis	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 3/12 • 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.
Gastrointestinal disorders Nausea	83.3% 10/12 • 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.
Nervous system disorders Neuropathy	58.3% 7/12 • 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.
Blood and lymphatic system disorders Neutropenia	41.7% 5/12 • 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.
Cardiac disorders Palpitation	33.3% 4/12 • 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.
Cardiac disorders Shortness of breath	8.3% 1/12 • 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.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • 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.
Gastrointestinal disorders Vomiting	41.7% 5/12 • 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.
Skin and subcutaneous tissue disorders skin toxicity	16.7% 2/12 • 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.

Additional Information

Franco Muggia, MD

NYU Cancer Institute

Phone: 212-263-6485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place