Clinical trial · Interventional
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
NCT00182754CI-TRIAL-00026915completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| octreotide acetate | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive octreotide subcutaneously (SC) once on day 1.
- interventionNames
- Drug: octreotide acetate
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive placebo SC once on day 1.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Median Time to Paracentesis
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.