Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
| 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
- 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.
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
68A total of 68 patients (34 per treatment arm) will be accrued for this study.
Outcomes
Primary Outcome(s)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 Lead Organizations
North Central Cancer Treatment Group
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| Aminah Jatoi, MD, Protocol chair | |
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| Paul Schaefer, MD, Protocol co-chair | |
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| Lynn Hartmann, MD, Protocol co-chair | |
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| Karin Giordano, MD, Protocol co-chair | |
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Related Information
| Registry Information | ||
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| Official Title | An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LAR® Depot) for Symptomatic Ascites in Cancer Patients | |
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| Trial Start Date | 2005-10-28 | |
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| Registered in ClinicalTrials.gov | NCT00182754 | |
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| Date Submitted to PDQ | 2005-12-07 | |
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| Information Last Verified | 2009-08-07 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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