octreotide in treating patients with cancer-related malignant ascites

Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: octreotide may be an effective treatment for malignant ascites. it is not yet known whether octreotide is more effective than a placebo in treating malignant ascites. purpose: this randomized phase iii trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

objectives: primary * compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites. secondary * compare the number of paracenteses in patients treated with these drugs. * determine the toxicity of octreotide in these patients. * compare the quality of life of patients treated with these drugs. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive octreotide subcutaneously (sc) once on day 1. * arm ii: patients receive placebo sc once on day 1. in both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity. quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment. after completion of study treatment, patients are followed every 6 months for up to 2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed cancer * diagnosis of malignant ascites, as determined by the treating oncologist * positive cytology not required * patient is symptomatic and views ascites as a problem * no lymphoma or lymphomatous ascites * planning therapeutic paracentesis ≤ 3 days after study entry or completed therapeutic paracentesis 2 days before study entry patient characteristics: age * 18 and over performance status * not specified life expectancy * at least 4 weeks hematopoietic * not at high risk of bleeding from a procedure hepatic * no known cirrhosis or portal hypertension renal * no known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * prior cholecystitis allowed provided patient underwent cholecystectomy * no uncontrolled diabetes mellitus * no known allergy to octreotide * no known allergy to latex * no medical condition that would preclude study treatment prior concurrent therapy: biologic therapy * no concurrent bevacizumab chemotherapy * no concurrent intraperitoneal chemotherapy * no concurrent first-line chemotherapy for any cancer except pancreatic cancer * concurrent second-line chemotherapy or later-line chemotherapy allowed endocrine therapy * no other concurrent octreotide radiotherapy * not specified surgery * not specified other * no concurrent therapeutic warfarin * concurrent prophylactic warfarin at a dose of 1 mg/day allowed * no other concurrent treatment for ascites except paracentesis or ongoing diuretics

Keywords: unspecified adult solid tumor, protocol specific malignant ascites