Congress Abstracts 2003

51

A PHASE I/II STUDY TO EVALUATE THE OPTIMUM DOSE OF PEGYLATED-INTERFERON IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN, PERITONEAL, OR FALLOPIAN TUBE CANCER: A NEW TREATMENT APPROACH FOR PATIENTS WITH RECURRENT DISEASE. Jacalyn Gano, RN, MSW, OCN^®, and Judith Wolf, MD, M.D. Anderson Cancer Center, Houston, TX.

Ovarian cancer is the leading cause of gynecologic cancer death in the United States. Most patients present with advanced disease and eventually relapse in spite of aggressive tumor reductive surgery and chemotherapy. Patients with peritoneal and fallopian tube cancers have a similar presentation. Unfortunately, responses to salvage chemotherapy in all three groups are disappointing. New agents are needed to improve responses and survival in these patients.

Interferons are a family of naturally occurring proteins that exert their multiple effects on cell proliferation and differentiation by binding to cell surface receptors. In addition to their antiproliferative effects, interferons down regulate bFGF and collagenase (agents involved in angiogenesis and metastasis). Interferons are active in several human tumors, including ovarian carcinomas. However, early studies of recombinant alpha interferon reported low response rates. Factors such as large tumor burden, short half-life, variations in dose and administration schedules, and frequent dose reductions due to toxicity may explain its limited activity. PEG-Intron is the union of interferon alpha 2b (Intron) and polyethylene glycol (PEG). The objective of conjugating Intron with PEG is to prolong plasma half-life, thus protracting the activity of the drug.

A clinical trial to establish the optimum dose of PEG-Intron is underway in patients with recurrent, platinum-resistant ovarian, peritoneal, or fallopian tube cancer. The potential utility of bFGF, VEGF, or IL-8 serum levels as surrogate biomarkers for predicting tumor response is also being studied. Eligible patients are randomized to either 1.0, 1.25, or 1.5 mcg/kg/week of PEG-Intron using a weighted randomization schema. Toxicity diaries and protocol compliance are monitored weekly by the research nurse. Patients are evaluated for response after 2 courses (8 weeks) of treatment. The most frequently reported side effects are asthenia, headache, flu-like symptoms, injection site reaction, rigors, myalgia, irritability, and depression. Reductions in neutrophils, white cells, and platelets have also been observed.

This presentation will review the protocol design and objectives, treatment plan, randomization schema, and patient response and toxicity data. The nurses’ role in protocol planning and implementation, interventions used to manage/minimize side effects, and protocol-specific educational materials and data collection tools will also be highlighted.