Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

Aminah Jatoi

Study Chair

Paul L. Schaefer

Lynn Carol Hartmann

Karin F. Giordano

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00182754
Information obtained from ClinicalTrials.gov on February 20, 2013

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