Octreotide in Treating Patients With Cancer-Related Malignant Ascites

• VEGF concentrations in ascitic fluid [ Designated as safety issue: No ]
• Number of paracenteses [ Designated as safety issue: No ]
• Toxicity incidence [ Designated as safety issue: Yes ]
• Average quality-of-life [ Designated as safety issue: No ]

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.

PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this study.

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

• Drug: octreotide acetate
  Given subcutaneously
• Other: placebo
  Given subcutaneously

• Experimental: Arm I
  Patients receive octreotide subcutaneously (SC) once on day 1.
  Intervention: Drug: octreotide acetate
• Placebo Comparator: Arm II
  Patients receive placebo SC once on day 1.
  Intervention: Other: placebo

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