Return to List

Study Summary
No. ID02-005:.......Head and Neck; Lung; CTRC(Translational Research)......Charles Lu......Thoracic and Head and Neck Medical Oncology
.
Study Summary Title
Study Summary
Number:
ID02-005
Study Title:A DOUBLE BLIND, PLACEBO CONTROLLED RANDOMIZED PHASE II TRIAL OF GEMCITABINE AND CISPLATIN WITH OR WITHOUT THE VEGF INHIBITOR BEVACIZUMAB IN PATIENTS WITH MALIGNANT MESOTHELIOMA
.
Physician New Patient Referral
Name:Charles LuPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic and Head and Neck Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713/792-6363
Contact us about clinical trials
.
General Information
Disease Group:Head and Neck
Lung
CTRC(Translational Research)
Supported By:NCI grant
Phase of Study:Phase IIReturn
Visit:
Patient must return on days 1 and 8 of each 3-week cycle.
Treatment
Agents:
LY 188011
Cisplatin
Bevacizumab
Home Care:None
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
.
Study Objectives / Outcomes
Unavailable
.
Study Status Information
Study Activation / Registration Date:05/17/2002
IRB Review and Approval Date:03/06/2002
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:24
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma, epithelial, sarcomatoid, or mixed subtype.

Pt must not be amenable to curative Tx by surgery. Second opinion by mesothelioma experienced surgeon confirming gross unresectability, or pts inability to tolerate resection, must be available.

Measurable disease by conventional techniques or spiral CT. Pleural effusions & ascites are not considered measurable lesions.

No prior cytotoxic chemo. Prior intrapleural cytotoxic agents (including bleomycin) are allowed.

Age >/= 18 yrs of age.

Life expectancy of > 3 months.

ECOG status 0-1.

Pts with pleural mesothelioma must be IMIG stage >/=II.

Labs:WBC>/=3000/ul; ANC>/=1500/ul;plt>/=100,000/ul;Total Bili within Normal limits, AST(SGOT)/ALT(SGPT)</=2.5xULN; Cr</=1.5mg/dL or CRCL>/=60ml/min;PT INR</=1.5.

At least 30 days must have passed before study entry for pts who have received an investigational drug.

Pts who have previously received radiation therapy are elig if site of measurable disease is not located within the radiation therapy port & >/=4 wks elapsed from completion of therapy & toxicity resolved.

Measurable disease sites are the discretion of the Principal Investigator. MRI may also serve as a radiologic assessment of disease.

Men & women of child bearing potential must agree to use birth control prior to and for duration of study participation.

Signed informed consent.

Exclusion Criteria:Pt may not be receiving any other investigational agents.

Pts with known brain mets should be excluded from this clinical trial because of poor prognosis & frequent development of progressive neurologic dysfunction, compounding evaluation & other adverse events.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Bevacizumab or other agents used in the study.

Tumor involvement of major vessels on CT scan, Hx of bleeding diathesis, CVA, PE or DVT, recent myocardial ischemia or infarction or uncompensated coronary artery disease within past 6 months, uncontrolled hypertension or sign. renal impairment.

Major surgery within prior 6 wks.

Currently active second malignancy other than non-melanoma skin or carcinoma in situ of the cervix. Pts with no evidence of recurrence for >/= 5 yrs are not considered to be "currently active."

Uncontrolled intercurrent illnesses that would limit compliance with study requirements.

Pregnant or nursing females.

HIV positive pts receiving combination anti-retroviral therapy.

Pts who have >/=1+ proteinuria at baseline must undergo 24 hr urine collection, which must demonstate <500 mg of protein/24 hrs to allow participation.

Pts w/recent (within 6mo) arterial thromboembolic events incl transient ischemic attach (TIA), cerebrovascular accident (CVA), unstable angina, or MI will be excluded. Pts w/clinically significant peripheral artery disease should also be excluded

.
Links
Registration Number:

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center