Mesothelioma Clinical Trials
Chemotherapy With or Without Bevacizumab in Treating Patients
With Malignant Mesothelioma
This study is currently
University of Chicago Cancer Research Center
For more information:National
Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop
growing or die. Monoclonal antibodies such as bevacizumab can
locate tumor cells and kill them without harming normal cells.
It is not yet known if combination chemotherapy is more
effective with or without bevacizumab in treating malignant
PURPOSE: Randomizedphase II trial to compare the
effectiveness of combination chemotherapy with or without
bevacizumab in treating patients who have malignant
| Drug: bevacizumab|
Procedure: biological response
Procedure: monoclonal antibody
This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional
Official Title: Phase II Randomized
Study of Gemcitabine and Cisplatin With or Without Bevacizumab
in Patients With Malignant Mesothelioma
Further Study Details:
- Compare the time to progression of patients with
malignant mesothelioma treated with gemcitabine and
cisplatin with or without bevacizumab.
- Compare the objective response rate in patients treated
with these regimens.
- Compare the toxicity of these regimens when administered
to these patients.
- Compare the median and overall survival of patients
treated with these regimens.
- Assess plasma vascular endothelial growth factor and
serum vascular cell adhesion molecule-1 levels before,
during, and after study therapy as predictors of outcome in
OUTLINE: This is a randomized, double-blind,
placebo-controlled, multicenter study. Patients are stratified
according to histology (epithelial vs other) and ECOG
performance status (0 vs 1). Patients are randomized to one of
two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes
on days 1 and 8 and cisplatin IV over 30-60 minutes
(beginning after gemcitabine infusion) and bevacizumab IV
over 30-90 minutes (beginning after cisplatin infusion) on
day 1. Treatment repeats every 3 weeks for 6 courses in the
absence of disease progression or unacceptable toxicity.
Patients who achieve stable disease (SD), complete response
(CR), or partial response (PR) after the sixth course may
receive bevacizumab as a single agent once every 3 weeks in
the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine and cisplatin as in
arm I and placebo IV over 30-90 minutes (beginning after
cisplatin infusion) on day 1. Treatment repeats as in arm I.
Patients who achieve SD, CR, or PR after the sixth course
may receive placebo as a single agent once every 3 weeks in
the absence of disease progression.
PROJECTED ACCRUAL: A total of 106 patients (53 per
treatment arm) will be accrued for this study within 16
Ages Eligible for Study: 18 Years and
above, Genders Eligible for Study: Both
- Histologically or cytologically confirmed malignant
pleural or peritoneal mesothelioma that is not amenable to
- Epithelial, sarcomatoid, or mixed subtype
- Evidence of gross unresectability, including, but not
limited to, the following conditions:
- Direct extension into the chest wall
- Mediastinal or hilar lymphadenopathy
- Pulmonary or cardiac function that is inadequate to
- Sarcomatoid or mixed histology
- Pleural mesothelioma must be stage II or greater using
the International Mesothelioma Interest Group staging system
- Measurable disease outside prior irradiation port
- At least 20 mm by conventional techniques OR at least 10
mm by spiral CT scan
- Pleural effusions and ascites are not considered
- Site in pleura, lung, liver, or retroperitoneum that can
be assessed by MRI for evaluation of blood flow
- No obvious tumor involvement of major vessels by CT scan
- No known brain metastases