Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Pentoxifylline to Prevent Weight Loss in Patients Who Are Undergoing Chemotherapy for Metastatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI URCC-U2994 URCC-2994PM, NCI-P97-0087

Objectives

I.   Determine whether pentoxifylline is effective in maintaining weight in 
patients undergoing chemotherapy for metastatic cancer.

Entry Criteria

Disease Characteristics:

Histologically diagnosed metastatic cancer of the lungs, breast, colon, or
upper gastrointestinal tract (including gastric, gastroesophageal, esophageal,
pancreatic, and hepatobiliary) in patients scheduled to receive at least 3
chemotherapy treatment cycles

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent biological response modifiers
 Cytokine therapy allowed

Chemotherapy:
 Last day of chemotherapy administration must be separated by at least 2 weeks 
  from the start of the next administration

Endocrine therapy:
 No concurrent corticosteroid as an integral part of treatment
 Corticosteroid as adjunct for antiemetic regimen allowed
 No concurrent anabolic steroids

Radiotherapy:
 No concurrent radiation therapy

Surgery:
 Not specified

Other:
 No parenteral nutrition
 No cyproheptadine
 No hydrazine sulfate
 No megestrol acetate
 No tetrahydrocannabinol (THC)
 Antidepressant medication allowed
 Metoclopramide allowed
 No concurrent anticoagulent therapy
 No treatment with platelet aggregation inhibitors

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 At least 3 months

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Creatinine less than 2 mg/dL

Expected Enrollment

267 patients will be accrued per arm for a total of 534 patients.

Outline

This is a double blind, placebo controlled, randomized study.

Patients are administered pentoxifylline starting on the seventh day following 
the last administration of chemotherapy in cycle 1 and continue the drug 
through 3 cycles of chemotherapy.  Pentoxifylline is administered by mouth 
tid.  

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jane T. Hickok, MD, MPH, Protocol chair		Ph: 585-275-5513