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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

Thank you

Trial Information

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


This was a planned Phase I/II dose escalation study. Patients were enrolled in a cohort of
3.

Eligible patients with unresectable pleural mesothelioma received frontline treatment
consisting of carboplatin AUC 5, bevacizumab 15 mg/kg, and pemetrexed 500 mg/m^2 every 21
days (Tier-1). Dose escalation continued to achieve a target dosage using carboplatin AUC 6
(Tier-2). After a maximum of 6 treatment cycles, non-progressing patients received
maintenance therapy with bevacizumab and pemetrexed every 21 days to complete 1-year total
treatment duration.


Inclusion Criteria:



- Patient must have histologically proven diagnosis of Malignant Pleural Mesothelioma
(MPM)

- Patient must have MPM with measurable disease.

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0,
1, or 2.

- Patient must have adequate renal function with a serum creatinine level of less than
1.5 mg/dl and patient should have a calculated creatinine clearance of more than
40ml/min.

- Patient must have adequate hepatic function with a serum bilirubin level of less that
3mg/dl, and an alkaline phosphatase, ALT and AST of less than five times the upper
limit of normal

- Patient must also have evidence of adequate bone marrow function with an absolute
neutrophil count of more than 1500 cells per deciliter and a platelet count of more
than 100,000 per deciliter.

- Patients must be more than 28 days since prior open biopsy; more than 7 days since
prior fine-needle aspiration; more than 7 days since prior core biopsy; more than 28
days since prior surgery.

- Patients must be able to take dexamethasone, folic acid, and vitamin B-12
supplementation.

- All patients must sign informed consent that will detail the investigational nature
of the study in accordance with the institutional and federal guidelines.

- Patients with clinically significant pleural effusions or ascites (symptomatic or
detectable by clinical exam) should have their effusions drained prior to enrollment
on the clinical trial.

Exclusion Criteria:

- Patients with hypercalcemia (corrected calcium of more than 11 mg/dl) will be
excluded.

- Patients with history of hemoptysis, haematemesis, coagulopathy or thrombosis will be
excluded.

- Patients requiring anticoagulation for any reason will be excluded.

- History of palliative radiation therapy within 2 weeks

- Blood pressure of >160/100 mmHg, despite adequate anti-hypertensive use.

- Currently ongoing unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure.

- History of stroke within 6 months

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to the day of initiation of treatment, anticipation of need for major surgical
procedure during the course of the study

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to the day of initiation of treatment.

- Pregnant (positive pregnancy test) or lactating

- Urine calculated creatinine clearance of less than 40ml/minute. - History of
abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

Laboratory Values:

- Patient must have adequate renal function with a serum creatinine level of less than
1.5 mg/dl and patient should have a calculated creatinine clearance of more than
40ml/min.

- Patient must have adequate hepatic function with a serum bilirubin level of less than
3 mg/dl, and an alkaline phosphatase, ALT and AST of less than five times the upper
limit of normal

- Patient must also have evidence of adequate bone marrow function with an absolute
neutrophil count of more than 1, 500 cells per deciliter and a platelet count of more
than 100,000 per deciliter.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Partial Response (PR) of Target Lesions

Outcome Description:

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.

Outcome Time Frame:

Up to 12 Months

Safety Issue:

No

Principal Investigator

Tawee Tanvetyanon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-14896

NCT ID:

NCT00604461

Start Date:

October 2007

Completion Date:

January 2011

Related Keywords:

  • Mesothelioma
  • Carboplatin
  • Bevacizumab
  • Avastin
  • Pemetrexed
  • Alimta
  • Mesothelioma

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612