Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Ascites
Intervention: octreotide acetate; placebo
Intervention description: Given subcutaneously; Given subcutaneously
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific; malignant ascites

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.
    

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