Octreotide in Treating Patients With Cancer-Related Malignant Ascites

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Octreotide

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