Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma

Conditions

• Advanced Malignant Mesothelioma
• Epithelial Mesothelioma
• Localized Malignant Mesothelioma
• Recurrent Malignant Mesothelioma
• Sarcomatous Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• gemcitabine hydrochloride — DRUG
  Given IV
• cisplatin — DRUG
  Given IV
• bevacizumab — BIOLOGICAL
  Given IV
• placebo — OTHER
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have malignant mesothelioma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known if combination chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.

Key Dates

First listed

Jan 27, 2003

Start date

Oct 31, 2001

Status verified

Dec 2012

Primary completion

May 31, 2006

Study Design

Enrollment

106 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Time to disease progression [ Time Frame: Time from randomization until the first evidence of progression, up to 9 years ]

Locations (1)

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