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Octreotide in Treating Patients With Cancer-Related Malignant Ascites
This study is ongoing, but not recruiting participants.
First Received: September 15, 2005   Last Updated: August 8, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182754
  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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Octreotide acetate Octreotide
U.S. FDA Resources

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
Arm I: Experimental
Patients receive octreotide subcutaneously (SC) once on day 1.
Drug: octreotide acetate
Given subcutaneously
Arm II: Placebo Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182754

  Show 122 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
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:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

No publications provided

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

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

Study placed in the following topic categories:
Antineoplastic Agents, Hormonal
Ascites
Neoplasm Metastasis
Octreotide

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

ClinicalTrials.gov processed this record on September 10, 2009



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