Octreotide in Treating Patients With Cancer-Related Malignant Ascites

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