Octreotide 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.

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