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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00840450
• Collaborator: Novartis (Industry)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 66
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Gleevec/Paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Paclitaxel + Imatinib Mesylate (Gleevec)

Drug: Gleevec/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.; Other Names: Gleevec:Imatinib Mesylate Paclitaxel: Taxol

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU cancer center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Novartis

Investigators

• Principal Investigator: Franco M Muggia, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• publication for this trial

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00840450
• Other Study ID Numbers: 06-226; CSTI57BUS224
• First Posted: Feb 10, 2009
• Last Update Posted: Nov 19, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by NYU Langone Health: ovarian cancer; recurrent; Gleevec; Paclitaxel; Taxane; mullerian
• Additional relevant MeSH terms: Ovarian Neoplasms; Paclitaxel; Albumin-Bound Paclitaxel; Imatinib Mesylate

Study Results

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.

Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
Period Title: Overall Study
STARTED	12
COMPLETED	9
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 66.7%
>=65 years	4 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (8)
Sex: Female, Male (Count of Participants)
Female	12 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%
Platinum Sensitivity (Number) [Number]
Resistant	10 83.3%
Sensitive	2 16.7%

Outcome Measures

1. Primary Outcome

Title	the Best Overall Clinical Response
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
Measure Participants	12
Number [percentage of participants]	33 275%

2. Secondary Outcome

Title	Progression-free-tolerance
Description	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

Outcome Measure Data

Analysis Population Description

Based on intent-to-treat population.

Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
Measure Participants	12
Number [percentage of participants]	75 625%

3. Secondary Outcome

Title	Progression-free-survival at 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

Based on intent-to-treat population.

Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
Measure Participants	12
Number [percentage of participants]	17 141.7%

Adverse Events

Time Frame	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.
Arm/Group Title	Paclitaxel and Imatinib Mesylate (Gleevec)
Arm/Group Description
All Cause Mortality
	Paclitaxel and Imatinib Mesylate (Gleevec)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel and Imatinib Mesylate (Gleevec)
	Affected / at Risk (%)	# Events
Total	3/12 (25%)
Blood and lymphatic system disorders
Neutropenia	2/12 (16.7%)	2
Thrombocytopenia	1/12 (8.3%)	1
Gastrointestinal disorders
Diarrhea	1/12 (8.3%)	1
Other (Not Including Serious) Adverse Events
	Paclitaxel and Imatinib Mesylate (Gleevec)
	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)
Blood and lymphatic system disorders
Anemia	11/12 (91.7%)
Neutropenia	5/12 (41.7%)
Thrombocytopenia	1/12 (8.3%)
Cardiac disorders
Palpitation	4/12 (33.3%)
Shortness of breath	1/12 (8.3%)
Gastrointestinal disorders
Diarrhea	5/12 (41.7%)
Mucostitis	1/12 (8.3%)
Nausea	10/12 (83.3%)
Vomiting	5/12 (41.7%)
General disorders
Alopecia	5/12 (41.7%)
Edema	2/12 (16.7%)
Fatigue	9/12 (75%)
Headache	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Myalgia	3/12 (25%)
Nervous system disorders
Neuropathy	7/12 (58.3%)
Skin and subcutaneous tissue disorders
skin toxicity	2/12 (16.7%)

Limitations/Caveats

Premature closure led to small numbers of subjects analyzed (12 out of 50 targeted accrual number).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.