Trial Outcomes & Findings for Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer (NCT NCT00928642)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.

Results posted on

2014-10-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Oral Imatinib Plus Gemcitabine Open label, non-randomized, single treatment group.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=8 Participants Open label, non-randomized, single treatment group.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=39 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 7.3 • n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	8 participants n=39 Participants

PRIMARY outcome

Timeframe: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.

Population: of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment

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.

Outcome measures

Outcome measures
Measure	Oral Imatinib Plus Gemcitabine n=7 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.
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.	0 participants

PRIMARY outcome

Timeframe: Until disease progression or unacceptable toxicity

Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria

Outcome measures

Outcome measures
Measure	Oral Imatinib Plus Gemcitabine n=8 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.
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 Grade 4 toxicity	1 participants
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 Red Blood Cell Transfusion	1 participants
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 Grade 3 toxicity	3 participants

SECONDARY outcome

Timeframe: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified

Population: All subjects who underwent treatment and participated in the study were analysed

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.

Outcome measures

Outcome measures
Measure	Oral Imatinib Plus Gemcitabine n=7 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.
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.	0 participants

SECONDARY outcome

Timeframe: Until death

All subjects were followed after treatment was complete to assess overall survival.

Outcome measures

Outcome measures
Measure	Oral Imatinib Plus Gemcitabine n=8 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.
To Determine the Distribution of the Overall Survival	9 months Interval 2.0 to 41.0

SECONDARY outcome

Timeframe: until disease progression or unacceptable toxicity

Population: All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals

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.

Outcome measures

Outcome measures
Measure	Oral Imatinib Plus Gemcitabine n=7 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.
To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)	0 participants

SECONDARY outcome

Timeframe: Until disease progression

The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=8 participants at risk Open label, non-randomized, single treatment group.
Skin and subcutaneous tissue disorders Cellulitis	12.5% 1/8 • Number of events 1 • 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.
Renal and urinary disorders Pyelonephritis	12.5% 1/8 • Number of events 1 • 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.
Immune system disorders Allergic Reaction	12.5% 1/8 • Number of events 1 • 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.
Blood and lymphatic system disorders Neutropenia	12.5% 1/8 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

COL David E. McCune, MD, MC

Madigan Army Medical Center

Phone: 253-968-1155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place