RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of the treatment on these patients. PURPOSE: Clinical trial to compare the effect of chemotherapy given by mouth with that of chemotherapy given by infusion on the quality of life of patients who have recurrent ovarian epithelial cancer.

Condition
recurrent ovarian epithelial cancer peritoneal cavity cancer Quality of Life

Further Study Details: 

OBJECTIVES: I. Determine the impact of oral versus parenteral chemotherapy on quality of life (QOL) in patients with recurrent ovarian epithelial cancer. II. Evaluate the QOL over time in this patient population. III. Determine the impact of disease symptoms, treatment side effects, performance status, and CA-125 levels on QOL assessment in this patient population.

PROTOCOL OUTLINE: Patients receive a baseline quality of life (QOL) assessment, an attitudes/preference survey, and a performance status assessment at the time of diagnosis of recurrent disease. Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines, prior treatment history, and patient preference. QOL and performance status assessments are obtained again at 3 and 6 months during treatment. Attitudes/preferences are assessed at 6 months. Patients are withdrawn from study if treatment regimen is changed from oral to IV, or from IV to oral during this 6 months.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study over 12 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Newly diagnosed recurrent ovarian epithelial cancer or recurrent primary peritoneal cancer as evidenced by new clinical or radiologic detected mass or rising serum CA-125 level
• No progressive disease with ongoing treatment

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: Fluent in English; Not pregnant or nursing

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

Study chairs or principal investigators

Phillip Y. Roland,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067589; NU-98Q3; NCI-G00-1694
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004909
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08