Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	NCCTG-N04C2 NCT00182754

Special Category: NCI Web site featured trial

Objectives

Primary

1. Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.

Secondary

1. Compare the number of paracenteses in patients treated with these drugs.
2. Determine the toxicity of octreotide in these patients.
3. Compare the quality of life of patients treated with these drugs.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Median time to paracentesis

VEGF concentrations in ascitic fluid
Number of paracenteses
Toxicity incidence
Average quality-of-life

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Paul Schaefer, MD, Protocol co-chair		Ph: 419-479-5605
Lynn Hartmann, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Karin Giordano, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Related Information

Featured trial article

Registry Information
Official Title		An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LAR® Depot) for Symptomatic Ascites in Cancer Patients
Trial Start Date		2005-10-28
Registered in ClinicalTrials.gov		NCT00182754
Date Submitted to PDQ		2005-12-07
Information Last Verified		2009-08-07

Back to Top