Trial Outcomes & Findings for Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM) (NCT NCT00604461)

Last Updated: 2017-03-23

Results Overview

Tumor response was assessed in 12 patients who had at least one follow-up computed tomography (CT) scan. Response Evaluation Criteria in Solid Tumors (RECIST) definition of Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 12 Months

Results posted on

2017-03-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation Followed by Maintenance Therapy n=13 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Customized	66 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

Population: All participants with baseline and at least one post-baseline target lesion measurement.

Outcome measures

Outcome measures
Measure	Dose Escalation Followed by Maintenance Therapy n=12 Participants 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.
Number of Participants With Partial Response (PR) of Target Lesions	4 participants

SECONDARY outcome

Timeframe: 2 Years, 9 Months

Population: All participants

The PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Dose Escalation Followed by Maintenance Therapy n=13 Participants 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.
Number of Months of Progression Free Survival (PFS)	7.8 Months Interval 0.0 to 16.3

Adverse Events

Dose Escalation Followed by Maintenance Therapy

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation Followed by Maintenance Therapy n=13 participants at risk 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.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
General disorders Death	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
General disorders Fatigue	15.4% 2/13 • Number of events 2 • 2 Years, 9 MOnths
Infections and infestations Infection	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
Blood and lymphatic system disorders Leukopenia	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
Respiratory, thoracic and mediastinal disorders Thromboembolism	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths

Other adverse events

Other adverse events
Measure	Dose Escalation Followed by Maintenance Therapy n=13 participants at risk 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.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
General disorders Anorexia	30.8% 4/13 • Number of events 4 • 2 Years, 9 MOnths
Cardiac disorders Cardiac Arrhythmia	7.7% 1/13 • Number of events 2 • 2 Years, 9 MOnths
Gastrointestinal disorders Constipation/Diarrhea	38.5% 5/13 • Number of events 8 • 2 Years, 9 MOnths
General disorders Dysgeusia	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
Renal and urinary disorders Elevated Creatinine	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
General disorders Epistaxis	15.4% 2/13 • Number of events 3 • 2 Years, 9 MOnths
Gastrointestinal disorders Fatigue	69.2% 9/13 • Number of events 18 • 2 Years, 9 MOnths
Skin and subcutaneous tissue disorders Herpes Zoster	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
Vascular disorders Hypertension	46.2% 6/13 • Number of events 8 • 2 Years, 9 MOnths
Gastrointestinal disorders Mucositis	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths
Gastrointestinal disorders Nausea/Vomiting	38.5% 5/13 • Number of events 11 • 2 Years, 9 MOnths
General disorders Pain	61.5% 8/13 • Number of events 18 • 2 Years, 9 MOnths
Skin and subcutaneous tissue disorders Skin Rash	7.7% 1/13 • Number of events 2 • 2 Years, 9 MOnths
Endocrine disorders Transaminitis	7.7% 1/13 • Number of events 1 • 2 Years, 9 MOnths

Additional Information

Tawee Tanvetyanon, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-3050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place