Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM)

This study has been terminated.

( Slow Accrual )

Study NCT00604461 Information provided by H. Lee Moffitt Cancer Center and Research Institute

First Received on January 17, 2008. Last Updated on January 3, 2012 History of Changes

Results First Received: November 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Mesothelioma
Intervention:	Drug: Carboplatin, Bevacizumab and Pemetrexed

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was Open to Accrual (recruiting) for a period of 2 years (10/04/07 through 10/05/09). Recruiting ended on 10/05/09 due to slow accrual, as requested by pharmaceutical company.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Dose Escalation Followed by Maintenance Therapy	A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Description

Dose Escalation Followed by Maintenance Therapy

A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.

B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Participant Flow: Overall Study

	Dose Escalation Followed by Maintenance Therapy
STARTED	13
COMPLETED	12 ^[1]
NOT COMPLETED	1

[1]	Death within 30 days of treatment occurred in 1 patient.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Dose Escalation Followed by Maintenance Therapy	A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Description

Dose Escalation Followed by Maintenance Therapy

B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Baseline Measures

	Dose Escalation Followed by Maintenance Therapy
Number of Participants [units: participants]	13
Age [units: participants]
<=18 years	0
Between 18 and 65 years	6
>=65 years	7
Age, Customized [units: years] Median ( Full Range )	66 ( 41 to 76 )
Gender [units: participants]
Female	1
Male	12
Region of Enrollment [units: participants]
United States	13

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Partial Response (PR) of Target Lesions [ Time Frame: Up to 12 Months ]

Show Outcome Measure 1

2. Secondary:

Number of Months of Progression Free Survival (PFS) [ Time Frame: 2 Years, 9 Months ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was closed early due to slow patient accrual. The planned accrual had been 44.

Results Point of Contact:

Name/Title: Tawee Tanvetyanon, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3050
e-mail: tawee.tanvetyanon@moffitt.org

No publications provided

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:	NCT00604461 History of Changes
Other Study ID Numbers:	MCC-14896, AVF3483s
Study First Received:	January 17, 2008
Results First Received:	November 17, 2011
Last Updated:	January 3, 2012
Health Authority:	United States: Institutional Review Board