Octreotide in Treating Patients With Cancer-Related Malignant Ascites

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182754
First received: September 15, 2005
Last updated: August 8, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: octreotide acetate
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Median time to paracentesis [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 68
Study Start Date: October 2005
Arms Assigned Interventions
Experimental: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
Drug: octreotide acetate
Given subcutaneously
Placebo Comparator: Arm II
Patients receive placebo SC once on day 1.
Other: placebo
Given subcutaneously

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182754

  Show 122 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: Paul L. Schaefer, MD Toledo Clinic, Incorporated - Main Clinic
Investigator: Lynn C. Hartmann, MD Mayo Clinic
Investigator: Karin F. Giordano, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00182754     History of Changes
Other Study ID Numbers: CDR0000440922, NCCTG-N04C2
Study First Received: September 15, 2005
Last Updated: August 8, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
malignant ascites

Additional relevant MeSH terms:
Ascites
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Pathologic Processes
Neoplastic Processes
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014